Bipolar Disorder
Conditions
Keywords
FK949E, Major depressive episode, patients
Brief summary
In period I, the treatment effect of FK949E was compared with that of placebo in a blind manner in bipolar disorder patients with major depressive episodes. In period II, the long-term safety and efficacy of FK949E was evaluated.
Detailed description
This study consisted of two parts. In Treatment Period I, FK949E or placebo was administered orally in a blind manner to bipolar disorder patients with major depressive episodes, with the aim of evaluating the superiority of FK949E over placebo and the dose response of two doses of FK949E based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) total score. In Treatment Period II, the long-term safety, efficacy and pharmacokinetics of open-label FK949E was evaluated in patients who completed Treatment Period I. An analysis was performed for data in Treatment Period I and another analysis was done for data in combined Treatment Periods I and II.
Interventions
DRUGFK949E
Taken by mouth (orally).
DRUGPlacebo
Taken by mouth (orally).
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bipolar I or II disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders Ver. 4 Text Revision (DSM-IV-TR,) with a major depressive episode * The Hamilton Depression Rating Scale (HAM-D17) total score of 20 points or more and HAM-D17 depressed mood score of 2 points or more * Able to participate in the study with understanding of and compliance with subject requirements during the study in the investigator's or subinvestigator's opinion
Exclusion criteria
* Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolar disorder, within the last 6 months before informed consent * Concurrence of DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status * The Young Mania Rating Scale (YMRS) total score of 13 points or more * Nine or more mood episodes within the last 12 months before informed consent * Lack of response to at least 6-week treatment with at least 2 antidepressants for the current major depressive episode in the investigator's or subinvestigator's opinion * History of abuse or dependence of alcohol or substances other than caffeine and nicotine * Treatment with a depot antipsychotic within the last 42 days before primary registration * Unable to stop taking mood stabilizers (lithium carbonate and/or sodium valproate), lamotrigine, antipsychotics, or antidepressants from 7 days before secondary registration * Unable to stop taking antiepileptics (except lamotrigine and sodium valproate), antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents, cerebral ameliorators, antidementia agents, or anorectics, except those specified as conditionally-allowed concomitant drugs, after primary registration * Electroconvulsive therapy within the last 76 days before primary registration * The current major depressive episode persisting for more than 12 months or less than 4 weeks before informed consent * A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 76 days before primary registration and been maintained on a fixed level at fixed frequency) * Documented or suspected conditions such as renal failure, hepatic failure, serious cardiac disease, hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS) (or to be a carrier of hepatitis B, hepatitis C, or AIDS) * Concurrence of malignancy or history of cured malignancy within 5 years * Concurrence of uncontrolled hypertension (defined as a systolic blood pressure of 180 mmHg or more, or a diastolic blood pressure of 110 mmHg or more at primary registration) or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator or sub-investigator * Concurrence of hypotension (defined as a systolic blood pressure of less than 100 mmHg at primary registration) or orthostatic hypotension * History of transient, idiopathic orthostatic hypotension, with or without pre-syncope symptoms or syncope, or a current condition susceptible to transient hypotension, such as dehydration and decreased blood volume * Concurrent or previous history of cerebrovascular disease or transient ischemic attack (TIA) * Abnormal laboratory or electrocardiographic findings considered clinically significant in the investigator's or subinvestigator's opinion (in reference to grade 3 of the Adverse Drug Reactions Severity Grading Criteria \[Notification No. 80 of the Safety Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare dated 29 June 1992\]) * Participation in another clinical study or post-marketing study within the last 12 weeks before informed consent * History of quetiapine therapy during the current major depressive episode * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline and Week 8 | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Number of Participants With MADRS Response (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
| Number of Participants With MADRS Response (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Number of Participants With MADRS Remission (Treatment Period I) | Weeks 1, 2, 3, 4, 6, 8 | MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
| Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. |
| Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52 | The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Number of Participants With HAM-D17 Response (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. |
| Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52 | A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). |
| Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill). |
| Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill). |
| Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Weeks 1, 2, 3, 4, 6, 8 | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. |
| CGI-BP-C: Mania (Combined Treatment Period I and II) | Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1) | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| CGI-BP-C: Depression (Treatment Period I) | Weeks 1, 2, 3, 4, 6, 8 | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. |
| CGI-BP-C: Depression (Combined Treatment Period I and II) | Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1) | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Weeks 1, 2, 3, 4, 6, 8 | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. |
| CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1) | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With Adverse Events (Treatment Period I) | Up to 8 weeks | An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. |
| Number of Participants With Adverse Events (Combined Treatment Period I and II) | Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E & FK949E 300 mg / FK949E groups, from week 0 to week 52) | An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups. |
| Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | Baseline and Weeks 4, 8 | The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. |
| Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52 | The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | Baseline and Weeks 4, 8 | The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). |
| Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52 | The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal. |
| Change From Baseline in YMRS (Combined Treatment Period I and II) | Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 | The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. |
| Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Weeks 4, 8 | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Weeks 4, 8 | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Change From Baseline in MADRS Total Score (Treatment Period I) | Baseline and Weeks 1, 2, 3, 4, 6, 8 | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10 |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
| Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4) | The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. |
Countries
Japan
Participant flow
Recruitment details
Japanese patients with bipolar I or bipolar II as specified in Diagnostic and Statistical Manual of Mental Disorders Ver. 4 Text Revision (DSM-IV-TR) whose most recent episode was diagnosed as a major depressive episode using the Mini-International Neuropsychiatric Interview (MINI) were recruited for this study.
Pre-assignment details
Assignment of participants to the FK949E 150 mg group was discontinued with implementation of Version 3.0 of the protocol.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II. | 177 |
| FK949E 150 mg After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II. | 74 |
| FK949E 300 mg After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II. | 179 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period I | Adverse Event | 5 | 4 | 21 |
| Treatment Period I | Changes in the Episodes | 3 | 0 | 2 |
| Treatment Period I | Did Not Receive Drug | 1 | 0 | 0 |
| Treatment Period I | Insufficient Response | 7 | 0 | 5 |
| Treatment Period I | Lost to Follow-up | 3 | 2 | 2 |
| Treatment Period I | Miscellaneous | 2 | 0 | 3 |
| Treatment Period I | Protocol Deviations | 3 | 1 | 1 |
| Treatment Period I | Withdrawal of Consent | 12 | 7 | 5 |
| Treatment Period I | Worsening of the Target Disease | 8 | 0 | 2 |
| Treatment Period II | Adverse Event | 13 | 8 | 20 |
| Treatment Period II | Changes in the Episodes | 1 | 0 | 5 |
| Treatment Period II | Did Not Meet Transition Criteria | 0 | 3 | 4 |
| Treatment Period II | Did Not Receive Drug | 4 | 0 | 0 |
| Treatment Period II | Insufficient Response | 2 | 4 | 6 |
| Treatment Period II | Lost to Follow-up | 1 | 5 | 3 |
| Treatment Period II | Miscellaneous | 5 | 3 | 7 |
| Treatment Period II | Protocol Deviations | 0 | 0 | 1 |
| Treatment Period II | Withdrawal of Consent | 28 | 2 | 16 |
| Treatment Period II | Worsening of the Target Disease | 1 | 4 | 2 |
Baseline characteristics
| Characteristic | Placebo | FK949E 150 mg | FK949E 300 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 38.8 Years STANDARD_DEVIATION 11 | 39.2 Years STANDARD_DEVIATION 10.2 | 38.1 Years STANDARD_DEVIATION 11.2 | 38.6 Years STANDARD_DEVIATION 10.9 |
| Number of Participants wirth MADRS Remission | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 101 Participants | 37 Participants | 93 Participants | 231 Participants |
| Sex: Female, Male Male | 76 Participants | 37 Participants | 86 Participants | 199 Participants |
| Total Hamilton Depression Rating Scale (HAM-D17) Score | 23.1 units on a scale STANDARD_DEVIATION 2.8 | 23.3 units on a scale STANDARD_DEVIATION 3.4 | 23.0 units on a scale STANDARD_DEVIATION 3 | 23.1 units on a scale STANDARD_DEVIATION 3 |
| Total Montgomery-Åsberg Depression Rating Scale (MADRS) score | 30.8 units on a scale STANDARD_DEVIATION 6.4 | 30.2 units on a scale STANDARD_DEVIATION 6.8 | 30.9 units on a scale STANDARD_DEVIATION 6.9 | 30.7 units on a scale STANDARD_DEVIATION 6.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 177 | 0 / 74 | 0 / 179 | 0 / 120 | 0 / 74 | 0 / 179 |
| other Total, other adverse events | 62 / 177 | 51 / 74 | 140 / 179 | 106 / 120 | 59 / 74 | 164 / 179 |
| serious Total, serious adverse events | 2 / 177 | 1 / 74 | 0 / 179 | 1 / 120 | 4 / 74 | 5 / 179 |
Outcome results
Primary
Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
Time frame: Baseline and Week 8
Population: FAS; Last observation carried forward (LOCF) imputation was used for end of Treatment Period I.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -10.1 units on a scale | Standard Deviation 10.9 |
| FK949E 150 mg | Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -14.4 units on a scale | Standard Deviation 11.4 |
| FK949E 300 mg | Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -12.6 units on a scale | Standard Deviation 11.4 |
Comparison: An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.p-value: 0.03495% CI: [-4.7, -0.2]ANCOVA
Secondary
CGI-BP-C: Depression (Combined Treatment Period I and II)
The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputtion was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 36 | 1.9 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 44 | 1.8 units on a scale | Standard Deviation 0.9 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 32 | 1.9 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 12 | 2.7 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 48 | 1.9 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 28 | 1.9 units on a scale | Standard Deviation 0.9 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 14 | 2.4 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 40 | 1.8 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 24 | 1.9 units on a scale | Standard Deviation 0.9 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 16 | 2.3 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 20 | 2.0 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 18 | 2.1 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | End of combined period | 2.0 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 52 | 1.8 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 36 | 1.8 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | End of combined period | 2.5 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 2 | 3.1 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 3 | 2.9 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 4 | 2.7 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 6 | 2.6 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 8 | 2.5 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 10 | 2.5 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 12 | 2.6 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 14 | 2.6 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 16 | 2.4 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 18 | 2.5 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 20 | 2.3 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 24 | 2.1 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 28 | 1.9 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 32 | 2.0 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 40 | 1.8 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 44 | 2.0 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 48 | 1.9 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 52 | 1.7 units on a scale | Standard Deviation 0.9 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 28 | 2.2 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 10 | 2.4 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 52 | 1.8 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 32 | 2.1 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 8 | 2.5 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 6 | 2.7 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 36 | 2.1 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 4 | 2.7 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 48 | 1.9 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 40 | 2.1 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 3 | 2.9 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 16 | 2.4 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | End of combined period | 2.6 units on a scale | Standard Deviation 1.4 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 18 | 2.2 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 2 | 3.1 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 20 | 2.2 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 14 | 2.4 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 44 | 1.9 units on a scale | Standard Deviation 0.9 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 24 | 2.2 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Combined Treatment Period I and II) | Week 12 | 2.4 units on a scale | Standard Deviation 1 |
Secondary
CGI-BP-C: Depression (Treatment Period I)
The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.
Time frame: Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CGI-BP-C: Depression (Treatment Period I) | Week 3 | 3.4 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Depression (Treatment Period I) | Week 2 | 3.6 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Depression (Treatment Period I) | Week 4 | 3.2 units on a scale | Standard Deviation 1.3 |
| Placebo | CGI-BP-C: Depression (Treatment Period I) | Week 1 | 3.7 units on a scale | Standard Deviation 0.8 |
| Placebo | CGI-BP-C: Depression (Treatment Period I) | Week 8 | 3.1 units on a scale | Standard Deviation 1.4 |
| Placebo | CGI-BP-C: Depression (Treatment Period I) | Week 6 | 3.2 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | CGI-BP-C: Depression (Treatment Period I) | Week 4 | 2.8 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Depression (Treatment Period I) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | CGI-BP-C: Depression (Treatment Period I) | Week 2 | 3.1 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Depression (Treatment Period I) | Week 3 | 2.9 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Depression (Treatment Period I) | Week 6 | 2.7 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Depression (Treatment Period I) | Week 8 | 2.6 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Treatment Period I) | Week 8 | 2.8 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Depression (Treatment Period I) | Week 6 | 2.8 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Depression (Treatment Period I) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | CGI-BP-C: Depression (Treatment Period I) | Week 3 | 3.0 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Depression (Treatment Period I) | Week 4 | 2.9 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Depression (Treatment Period I) | Week 2 | 3.2 units on a scale | Standard Deviation 1 |
Secondary
CGI-BP-C: Mania (Combined Treatment Period I and II)
The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 36 | 4.0 units on a scale | Standard Deviation 0.3 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 44 | 4.0 units on a scale | Standard Deviation 0.4 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 14 | 3.9 units on a scale | Standard Deviation 0.5 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 32 | 4.0 units on a scale | Standard Deviation 0.4 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 28 | 3.9 units on a scale | Standard Deviation 0.4 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 16 | 3.9 units on a scale | Standard Deviation 0.5 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 48 | 4.0 units on a scale | Standard Deviation 0.4 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 40 | 4.0 units on a scale | Standard Deviation 0.3 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 18 | 3.9 units on a scale | Standard Deviation 0.5 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 20 | 3.9 units on a scale | Standard Deviation 0.5 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 12 | 4.0 units on a scale | Standard Deviation 0.4 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 52 | 3.9 units on a scale | Standard Deviation 0.4 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 24 | 4.0 units on a scale | Standard Deviation 0.5 |
| Placebo | CGI-BP-C: Mania (Combined Treatment Period I and II) | End of combined treatment period | 4.0 units on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 14 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | End of combined treatment period | 3.9 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 16 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 4 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 20 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 2 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 6 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 24 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 28 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 32 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 8 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 36 | 4.0 units on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 3 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 40 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 10 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 44 | 4.0 units on a scale | Standard Deviation 0 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 1 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 48 | 4.0 units on a scale | Standard Deviation 0 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 52 | 4.0 units on a scale | Standard Deviation 0 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 12 | 4.0 units on a scale | Standard Deviation 0.1 |
| FK949E 150 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 18 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 24 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | End of combined treatment period | 4.1 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 1 | 4.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 2 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 3 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 18 | 4.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 4 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 6 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 8 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 10 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 12 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 14 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 16 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 20 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 52 | 4.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 28 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 32 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 36 | 4.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 40 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 44 | 4.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | CGI-BP-C: Mania (Combined Treatment Period I and II) | Week 48 | 4.0 units on a scale | Standard Deviation 0.2 |
Secondary
CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)
The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 12 | 2.7 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 44 | 1.8 units on a scale | Standard Deviation 0.9 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 28 | 1.9 units on a scale | Standard Deviation 0.9 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 14 | 2.4 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | End of combined treatment period | 2.1 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 24 | 1.9 units on a scale | Standard Deviation 0.9 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 16 | 2.3 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 40 | 1.8 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 20 | 2.0 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 18 | 2.1 units on a scale | Standard Deviation 1.1 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 48 | 1.9 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 36 | 1.9 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 52 | 1.8 units on a scale | Standard Deviation 1 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 32 | 2.0 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 48 | 1.9 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 2 | 3.1 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 3 | 2.9 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 4 | 2.7 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 6 | 2.6 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 8 | 2.5 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 10 | 2.5 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 12 | 2.6 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 14 | 2.6 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 16 | 2.4 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 18 | 2.5 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 20 | 2.3 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 24 | 2.1 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 28 | 1.9 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 32 | 2.1 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 36 | 1.9 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 40 | 1.8 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 44 | 2.0 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 52 | 1.7 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | End of combined treatment period | 2.5 units on a scale | Standard Deviation 1.4 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 10 | 2.4 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 48 | 2.0 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 32 | 2.2 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 8 | 2.5 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 2 | 3.2 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 36 | 2.1 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 6 | 2.7 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | End of combined treatment period | 2.7 units on a scale | Standard Deviation 1.5 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 40 | 2.1 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 4 | 2.7 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 18 | 2.2 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 16 | 2.4 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 44 | 1.9 units on a scale | Standard Deviation 0.9 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 20 | 2.3 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 14 | 2.4 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 3 | 2.9 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 24 | 2.2 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 12 | 2.4 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 52 | 1.8 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 28 | 2.2 units on a scale | Standard Deviation 1.2 |
Secondary
CGI-BP-C: Overall Bipolar Illness (Treatment Period I)
The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.
Time frame: Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 8 | 3.1 units on a scale | Standard Deviation 1.5 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 4 | 3.3 units on a scale | Standard Deviation 1.3 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 3 | 3.4 units on a scale | Standard Deviation 1.2 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 1 | 3.7 units on a scale | Standard Deviation 0.8 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 6 | 3.3 units on a scale | Standard Deviation 1.4 |
| Placebo | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 2 | 3.6 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 6 | 2.7 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 8 | 2.6 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 2 | 3.1 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 3 | 2.9 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 4 | 2.8 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 3 | 3.0 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 1 | 3.5 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 4 | 2.9 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 6 | 2.9 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 8 | 2.8 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | CGI-BP-C: Overall Bipolar Illness (Treatment Period I) | Week 2 | 3.2 units on a scale | Standard Deviation 1 |
Secondary
Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)
The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 14 | -0.3 units on a sale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 18 | -0.7 units on a sale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 16 | -0.5 units on a sale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 52 | -0.9 units on a sale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 20 | -0.7 units on a sale | Standard Deviation 1 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 44 | -0.9 units on a sale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 40 | -0.9 units on a sale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 24 | -0.8 units on a sale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | End of combined treatment period | -0.8 units on a sale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 36 | -0.9 units on a sale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 28 | -0.8 units on a sale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 48 | -0.9 units on a sale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 32 | -0.8 units on a sale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 8 | -1.5 units on a sale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 18 | -1.7 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 4 | -1.2 units on a sale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 20 | -1.8 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 10 | -1.5 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 3 | -1.0 units on a sale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 24 | -2.1 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 28 | -2.4 units on a sale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 12 | -1.5 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 32 | -2.4 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 6 | -1.4 units on a sale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 36 | -2.6 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 40 | -2.5 units on a sale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 14 | -1.5 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 44 | -2.3 units on a sale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 2 | -0.8 units on a sale | Standard Deviation 1.1 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 48 | -2.5 units on a sale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 52 | -2.7 units on a sale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 16 | -1.7 units on a sale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | End of combined treatment period | -1.8 units on a sale | Standard Deviation 1.6 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 1 | -0.5 units on a sale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | End of combined treatment period | -1.6 units on a sale | Standard Deviation 1.5 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 1 | -0.4 units on a sale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 2 | -0.7 units on a sale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 3 | -1.0 units on a sale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 4 | -1.2 units on a sale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 6 | -1.3 units on a sale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 8 | -1.5 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 10 | -1.6 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 12 | -1.7 units on a sale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 14 | -1.7 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 16 | -1.7 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 18 | -2.0 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 20 | -1.9 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 24 | -2.0 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 28 | -2.0 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 32 | -2.1 units on a sale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 36 | -2.0 units on a sale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 40 | -2.1 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 44 | -2.2 units on a sale | Standard Deviation 1.1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 48 | -2.3 units on a sale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II) | Week 52 | -2.4 units on a sale | Standard Deviation 1.2 |
Secondary
Change From Baseline in CGI-BP-S: Depression (Treatment Period I)
The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 1 | -0.3 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 2 | -0.5 units on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 3 | -0.7 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 4 | -0.8 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 6 | -0.9 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 8 | -1.0 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 4 | -1.2 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 3 | -1.0 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 8 | -1.4 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 6 | -1.3 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 1 | -0.5 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 2 | -0.8 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 6 | -1.1 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 2 | -0.7 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 3 | -0.9 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 1 | -0.4 units on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 4 | -1.1 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Depression (Treatment Period I) | Week 8 | -1.2 units on a scale | Standard Deviation 1.3 |
Secondary
Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)
The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 14 | -0.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 18 | -0.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 16 | -0.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 52 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 20 | -0.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 44 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 40 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 24 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | End of combined treatment period | -0.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 36 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 28 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 48 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 32 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 8 | -0.0 units on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 18 | -0.1 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 4 | 0.0 units on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 20 | -0.1 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 10 | -0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 24 | -0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 3 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 28 | -0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 12 | 0.0 units on a scale | Standard Deviation 0.1 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 32 | 0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 6 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 36 | -0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 40 | 0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 14 | -0.1 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 44 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 2 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 48 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 52 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 16 | -0.1 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | End of combined treatment period | -0.1 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 1 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | End of combined treatment period | 0.1 units on a scale | Standard Deviation 0.5 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 1 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 2 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 3 | 0.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 4 | 0.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 6 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 8 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 10 | 0.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 12 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 14 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 16 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 18 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 20 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 24 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 28 | 0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 32 | 0.0 units on a scale | Standard Deviation 0.5 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 36 | -0.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 40 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 44 | -0.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 48 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II) | Week 52 | -0.0 units on a scale | Standard Deviation 0.1 |
Secondary
Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)
The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 32 | -0.8 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 14 | -0.3 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 48 | -0.9 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 28 | -0.9 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 16 | -0.5 units on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 40 | -1.0 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 24 | -0.8 units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 18 | -0.7 units on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 20 | -0.8 units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 44 | -1.0 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 52 | -1.0 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 36 | -0.9 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | End of combined treatment period | -0.8 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 40 | -2.3 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 2 | -0.7 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 4 | -1.1 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 6 | -1.3 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 8 | -1.4 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 10 | -1.4 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 12 | -1.4 units on a scale | Standard Deviation 1.5 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 14 | -1.4 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 16 | -1.6 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 20 | -1.7 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 24 | -2.0 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 28 | -2.2 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 32 | -2.2 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 36 | -2.4 units on a scale | Standard Deviation 1.5 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 44 | -2.2 units on a scale | Standard Deviation 1.5 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 48 | -2.4 units on a scale | Standard Deviation 1.5 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 52 | -2.6 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | End of combined treatment period | -1.7 units on a scale | Standard Deviation 1.6 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 3 | -0.9 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 18 | -1.6 units on a scale | Standard Deviation 1.4 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 1 | -0.4 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | End of combined treatment period | -1.5 units on a scale | Standard Deviation 1.5 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 40 | -2.1 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 8 | -1.5 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 2 | -0.7 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 44 | -2.2 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 6 | -1.3 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 36 | -2.0 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 48 | -2.3 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 4 | -1.2 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 1 | -0.4 units on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 20 | -1.9 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 16 | -1.7 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 52 | -2.4 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 24 | -1.9 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 14 | -1.6 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 3 | -1.0 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 28 | -1.9 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 12 | -1.7 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 18 | -1.9 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 32 | -2.0 units on a scale | Standard Deviation 1.3 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II) | Week 10 | -1.6 units on a scale | Standard Deviation 1.4 |
Secondary
Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)
The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 1 | -0.3 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 2 | -0.5 units on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 3 | -0.7 units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 4 | -0.8 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 8 | -1.0 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 6 | -0.8 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 6 | -1.2 units on a scale | Standard Deviation 1.2 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 1 | -0.4 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 4 | -1.1 units on a scale | Standard Deviation 1.1 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 8 | -1.4 units on a scale | Standard Deviation 1.3 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 2 | -0.7 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 3 | -0.9 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 2 | -0.7 units on a scale | Standard Deviation 0.9 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 3 | -0.9 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 4 | -1.1 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 6 | -1.1 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 1 | -0.4 units on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I) | Week 8 | -1.2 units on a scale | Standard Deviation 1.3 |
Secondary
Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)
The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 1 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 2 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 3 | 0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 4 | 0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 6 | 0.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 8 | 0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 8 | -0.1 units on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 1 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 4 | -0.0 units on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 6 | -0.1 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 2 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 3 | -0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 2 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 3 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 8 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 4 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 1 | 0.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I) | Week 6 | 0.0 units on a scale | Standard Deviation 0.3 |
Secondary
Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)
The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | End of combined treatment period | -0.0 umits on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 52 | -0.0 umits on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 20 | 0.0 umits on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 44 | -0.0 umits on a scale | Standard Deviation 0.2 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 36 | -0.1 umits on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 28 | -0.0 umits on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 16 | 0.0 umits on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 20 | -0.0 umits on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 4 | -0.1 umits on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 12 | 0.0 umits on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 28 | -0.1 umits on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 36 | -0.1 umits on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 44 | -0.1 umits on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 52 | -0.1 umits on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | End of combined treatment period | -0.1 umits on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 16 | -0.0 umits on a scale | Standard Deviation 0.6 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 8 | -0.1 umits on a scale | Standard Deviation 0.5 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | End of combined treatment period | -0.1 umits on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 52 | -0.2 umits on a scale | Standard Deviation 0.9 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 4 | 0.0 umits on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 8 | -0.1 umits on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 12 | -0.1 umits on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 16 | -0.1 umits on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 20 | -0.1 umits on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 28 | -0.1 umits on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 44 | -0.1 umits on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II) | Week 36 | -0.1 umits on a scale | Standard Deviation 0.7 |
Secondary
Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)
The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe).
Time frame: Baseline and Weeks 4, 8
Population: SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | End of Treatment Period I | 0.1 units on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | Week 4 | 0.0 units on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | Week 8 | 0.0 units on a scale | Standard Deviation 0.3 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | Week 8 | -0.1 units on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | End of Treatment Period I | -0.1 units on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | Week 4 | -0.1 units on a scale | Standard Deviation 0.5 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | Week 4 | 0.0 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | End of Treatment Period I | -0.1 units on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I) | Week 8 | -0.1 units on a scale | Standard Deviation 0.8 |
Secondary
Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)
The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 52 | 0.1 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 36 | 0.0 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 20 | 0.1 units on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | End of combined treatment period | 0.1 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 28 | 0.1 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 44 | 0.0 units on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 16 | 0.2 units on a scale | Standard Deviation 0.9 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 4 | 0.0 units on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 8 | 0.0 units on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 12 | 0.1 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 16 | 0.1 units on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 20 | 0.1 units on a scale | Standard Deviation 1 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 28 | -0.0 units on a scale | Standard Deviation 0.6 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 36 | 0.0 units on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 44 | -0.0 units on a scale | Standard Deviation 0.6 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 52 | 0.0 units on a scale | Standard Deviation 0.6 |
| FK949E 150 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | End of combined treatment period | -0.0 units on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 36 | -0.1 units on a scale | Standard Deviation 0.8 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 12 | 0.1 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 4 | 0.2 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 44 | -0.1 units on a scale | Standard Deviation 0.9 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 8 | 0.1 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 20 | 0.1 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | End of combined treatment period | 0.0 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 28 | 0.0 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 16 | 0.1 units on a scale | Standard Deviation 1 |
| FK949E 300 mg | Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II) | Week 52 | -0.2 units on a scale | Standard Deviation 1 |
Secondary
Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)
The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity.
Time frame: Baseline and Weeks 4, 8
Population: SAF participants with available data at each time point; LOCF was used for end of Treatment Period I.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | End of Treatment Period I | 0.1 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | Week 4 | 0.0 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | Week 8 | 0.1 units on a scale | Standard Deviation 0.5 |
| FK949E 150 mg | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | Week 8 | 0.0 units on a scale | Standard Deviation 0.7 |
| FK949E 150 mg | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | End of Treatment Period I | 0.0 units on a scale | Standard Deviation 0.8 |
| FK949E 150 mg | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | Week 4 | 0.0 units on a scale | Standard Deviation 0.7 |
| FK949E 300 mg | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | Week 4 | 0.2 units on a scale | Standard Deviation 1.2 |
| FK949E 300 mg | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | End of Treatment Period I | 0.1 units on a scale | Standard Deviation 1.1 |
| FK949E 300 mg | Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I) | Week 8 | 0.1 units on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in HAM-D17 (Combined Treatment Period I and II)
The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 36 | -4.9 units on a scale | Standard Deviation 6.4 |
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 28 | -4.8 units on a scale | Standard Deviation 6 |
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 52 | -5.6 units on a scale | Standard Deviation 7.1 |
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 20 | -4.2 units on a scale | Standard Deviation 6 |
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | End of combined treatment period | -4.6 units on a scale | Standard Deviation 6.6 |
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 16 | -2.9 units on a scale | Standard Deviation 5.2 |
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 44 | -5.7 units on a scale | Standard Deviation 7 |
| Placebo | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 14 | -1.9 units on a scale | Standard Deviation 4.7 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 16 | -13.7 units on a scale | Standard Deviation 7.1 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 2 | -8.8 units on a scale | Standard Deviation 5.8 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 3 | -10.3 units on a scale | Standard Deviation 6 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 4 | -11.4 units on a scale | Standard Deviation 6.5 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 6 | -12.7 units on a scale | Standard Deviation 7 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 8 | -13.0 units on a scale | Standard Deviation 7.1 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 10 | -13.1 units on a scale | Standard Deviation 7.8 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 12 | -13.7 units on a scale | Standard Deviation 7.5 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 14 | -13.9 units on a scale | Standard Deviation 7.5 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 1 | -5.9 units on a scale | Standard Deviation 5.1 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 20 | -14.6 units on a scale | Standard Deviation 7.3 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 28 | -16.7 units on a scale | Standard Deviation 6.4 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 36 | -17.1 units on a scale | Standard Deviation 6.9 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 44 | -17.0 units on a scale | Standard Deviation 7.6 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 52 | -17.8 units on a scale | Standard Deviation 7.9 |
| FK949E 150 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | End of combined treatment period | -12.9 units on a scale | Standard Deviation 8.7 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 20 | -13.8 units on a scale | Standard Deviation 6.6 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 6 | -10.7 units on a scale | Standard Deviation 6.8 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 52 | -16.2 units on a scale | Standard Deviation 6.7 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 28 | -14.3 units on a scale | Standard Deviation 7 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 2 | -7.1 units on a scale | Standard Deviation 5.8 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 36 | -14.6 units on a scale | Standard Deviation 6.8 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 4 | -9.9 units on a scale | Standard Deviation 6.3 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 1 | -4.5 units on a scale | Standard Deviation 4.9 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 12 | -12.6 units on a scale | Standard Deviation 6.5 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 44 | -15.1 units on a scale | Standard Deviation 6.9 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 14 | -12.8 units on a scale | Standard Deviation 7.1 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 10 | -12.4 units on a scale | Standard Deviation 7.2 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 3 | -8.4 units on a scale | Standard Deviation 6.1 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 16 | -13.4 units on a scale | Standard Deviation 6.9 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | Week 8 | -11.6 units on a scale | Standard Deviation 7.2 |
| FK949E 300 mg | Change From Baseline in HAM-D17 (Combined Treatment Period I and II) | End of combined treatment period | -11.6 units on a scale | Standard Deviation 8.3 |
Secondary
Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)
The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 1 | -3.4 units on a scale | Standard Deviation 4.2 |
| Placebo | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 2 | -5.1 units on a scale | Standard Deviation 5.4 |
| Placebo | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 3 | -6.6 units on a scale | Standard Deviation 6.5 |
| Placebo | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 4 | -7.3 units on a scale | Standard Deviation 6.7 |
| Placebo | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 6 | -7.7 units on a scale | Standard Deviation 7.3 |
| Placebo | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 8 | -8.4 units on a scale | Standard Deviation 7.6 |
| FK949E 150 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 3 | -10.0 units on a scale | Standard Deviation 6.2 |
| FK949E 150 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 4 | -10.9 units on a scale | Standard Deviation 6.6 |
| FK949E 150 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 8 | -11.9 units on a scale | Standard Deviation 7.4 |
| FK949E 150 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 1 | -5.9 units on a scale | Standard Deviation 5.1 |
| FK949E 150 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 6 | -11.9 units on a scale | Standard Deviation 7.1 |
| FK949E 150 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 2 | -8.7 units on a scale | Standard Deviation 5.8 |
| FK949E 300 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 1 | -4.5 units on a scale | Standard Deviation 4.9 |
| FK949E 300 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 6 | -9.6 units on a scale | Standard Deviation 7 |
| FK949E 300 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 3 | -7.9 units on a scale | Standard Deviation 6.2 |
| FK949E 300 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 8 | -10.1 units on a scale | Standard Deviation 7.6 |
| FK949E 300 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 2 | -7.0 units on a scale | Standard Deviation 6 |
| FK949E 300 mg | Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I) | Week 4 | -9.2 units on a scale | Standard Deviation 6.4 |
Comparison: At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.p-value: 0.03395% CI: [-3.3, -0.1]ANCOVA
Secondary
Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)
The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: FAS for combined Treatment Period I and II, which included participants who received at least one dose of FK949E and had measurements taken for at least one efficacy endpoint after the start of FK949E treatment, and with available data at each time point. LOCF imputation method was used at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 13 | -1.6 units on a scale | Standard Deviation 5.8 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 44 | -8.1 units on a scale | Standard Deviation 10 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 24 | -7.1 units on a scale | Standard Deviation 8.5 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | End of combined treatment period | -6.6 units on a scale | Standard Deviation 10.4 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 40 | -8.2 units on a scale | Standard Deviation 9.8 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 32 | -6.6 units on a scale | Standard Deviation 10.2 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 16 | -4.3 units on a scale | Standard Deviation 7.7 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 36 | -7.5 units on a scale | Standard Deviation 9.4 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 14 | -3.1 units on a scale | Standard Deviation 7 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 52 | -7.8 units on a scale | Standard Deviation 10.7 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 18 | -6.8 units on a scale | Standard Deviation 8 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 28 | -7.0 units on a scale | Standard Deviation 8.6 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 48 | -7.6 units on a scale | Standard Deviation 10 |
| Placebo | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 20 | -6.8 units on a scale | Standard Deviation 8.3 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 28 | -22.9 units on a scale | Standard Deviation 8.5 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 10 | -16.3 units on a scale | Standard Deviation 11.6 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 12 | -16.4 units on a scale | Standard Deviation 12.1 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 16 | -17.1 units on a scale | Standard Deviation 10.3 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 18 | -17.3 units on a scale | Standard Deviation 11.5 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 20 | -18.7 units on a scale | Standard Deviation 10.6 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 24 | -21.4 units on a scale | Standard Deviation 10.5 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 32 | -22.3 units on a scale | Standard Deviation 9.6 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 36 | -23.1 units on a scale | Standard Deviation 10.4 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 40 | -23.3 units on a scale | Standard Deviation 9.7 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 44 | -23.4 units on a scale | Standard Deviation 10.2 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 48 | -24.1 units on a scale | Standard Deviation 10.2 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 52 | -24.4 units on a scale | Standard Deviation 10.1 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | End of combined treatment period | -16.0 units on a scale | Standard Deviation 13.3 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 1 | -6.4 units on a scale | Standard Deviation 8.1 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 2 | -10.0 units on a scale | Standard Deviation 8.9 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 3 | -12.0 units on a scale | Standard Deviation 10.1 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 4 | -13.1 units on a scale | Standard Deviation 11 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 8 | -15.8 units on a scale | Standard Deviation 11.5 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 13 | -18.1 units on a scale | Standard Deviation 10.4 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 14 | -17.0 units on a scale | Standard Deviation 10.7 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 6 | -15.6 units on a scale | Standard Deviation 11.2 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 52 | -22.1 units on a scale | Standard Deviation 9.3 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 14 | -16.4 units on a scale | Standard Deviation 10.7 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 8 | -14.8 units on a scale | Standard Deviation 10.9 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | End of combined treatment period | -15.2 units on a scale | Standard Deviation 12.2 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 12 | -16.0 units on a scale | Standard Deviation 10.3 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 1 | -5.1 units on a scale | Standard Deviation 6.8 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 24 | -18.4 units on a scale | Standard Deviation 10.2 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 2 | -8.5 units on a scale | Standard Deviation 8.7 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 32 | -19.4 units on a scale | Standard Deviation 10.3 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 13 | -13.3 units on a scale | Standard Deviation 10.1 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 36 | -19.4 units on a scale | Standard Deviation 10.5 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 28 | -19.4 units on a scale | Standard Deviation 10.4 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 3 | -10.6 units on a scale | Standard Deviation 9.3 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 40 | -19.8 units on a scale | Standard Deviation 10.4 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 20 | -18.2 units on a scale | Standard Deviation 9.9 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 10 | -15.9 units on a scale | Standard Deviation 10.9 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 44 | -20.7 units on a scale | Standard Deviation 9.7 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 18 | -19.0 units on a scale | Standard Deviation 9.8 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 4 | -13.2 units on a scale | Standard Deviation 9.2 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 48 | -20.9 units on a scale | Standard Deviation 10.7 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 16 | -17.2 units on a scale | Standard Deviation 10.2 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Combined Treatment Period I and II) | Week 6 | -13.8 units on a scale | Standard Deviation 10.8 |
Secondary
Change From Baseline in MADRS Total Score (Treatment Period I)
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 1 | -3.5 units on a scale | Standard Deviation 5.4 |
| Placebo | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 2 | -5.1 units on a scale | Standard Deviation 7 |
| Placebo | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 3 | -7.1 units on a scale | Standard Deviation 8.8 |
| Placebo | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 4 | -8.5 units on a scale | Standard Deviation 9.1 |
| Placebo | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 6 | -9.2 units on a scale | Standard Deviation 10.1 |
| Placebo | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 8 | -10.1 units on a scale | Standard Deviation 10.9 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 8 | -14.4 units on a scale | Standard Deviation 11.4 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 1 | -6.4 units on a scale | Standard Deviation 8.1 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 4 | -12.5 units on a scale | Standard Deviation 10.8 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 6 | -14.5 units on a scale | Standard Deviation 11 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 2 | -10.0 units on a scale | Standard Deviation 8.9 |
| FK949E 150 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 3 | -11.6 units on a scale | Standard Deviation 9.9 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 2 | -8.3 units on a scale | Standard Deviation 8.6 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 3 | -9.9 units on a scale | Standard Deviation 9.3 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 8 | -12.6 units on a scale | Standard Deviation 11.4 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 4 | -11.8 units on a scale | Standard Deviation 9.5 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 1 | -5.1 units on a scale | Standard Deviation 6.8 |
| FK949E 300 mg | Change From Baseline in MADRS Total Score (Treatment Period I) | Week 6 | -12.2 units on a scale | Standard Deviation 10.9 |
Secondary
Change From Baseline in YMRS (Combined Treatment Period I and II)
The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 52 | -0.8 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 28 | -0.7 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 13 | -0.3 units on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 44 | -0.5 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 24 | -0.6 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 14 | -0.4 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | End of combined treatment period | -0.5 units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 20 | -0.5 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 16 | -0.5 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 40 | -0.8 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 18 | -0.7 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 48 | -0.7 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 36 | -0.7 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 32 | -0.7 units on a scale | Standard Deviation 1.6 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 48 | -1.9 units on a scale | Standard Deviation 2.1 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 10 | -1.6 units on a scale | Standard Deviation 2.1 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 1 | -0.6 units on a scale | Standard Deviation 1.8 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 3 | -1.2 units on a scale | Standard Deviation 1.7 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 4 | -1.3 units on a scale | Standard Deviation 2 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 6 | -1.4 units on a scale | Standard Deviation 2.1 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 8 | -1.7 units on a scale | Standard Deviation 2.3 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 12 | -1.2 units on a scale | Standard Deviation 1.6 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 13 | -1.3 units on a scale | Standard Deviation 1.6 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 14 | -1.6 units on a scale | Standard Deviation 1.9 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 16 | -1.3 units on a scale | Standard Deviation 2.1 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 18 | -1.6 units on a scale | Standard Deviation 2 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 20 | -1.5 units on a scale | Standard Deviation 2.2 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 24 | -1.4 units on a scale | Standard Deviation 1.9 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 28 | -1.6 units on a scale | Standard Deviation 2 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 32 | -1.4 units on a scale | Standard Deviation 2.4 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 36 | -1.3 units on a scale | Standard Deviation 2.4 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 40 | -1.6 units on a scale | Standard Deviation 2.1 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 44 | -1.7 units on a scale | Standard Deviation 1.9 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 2 | -1.0 units on a scale | Standard Deviation 1.5 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 52 | -1.9 units on a scale | Standard Deviation 2 |
| FK949E 150 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | End of combined treatment period | -1.6 units on a scale | Standard Deviation 2 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 28 | -1.1 units on a scale | Standard Deviation 2 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 10 | -0.8 units on a scale | Standard Deviation 2.1 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 48 | -1.3 units on a scale | Standard Deviation 1.5 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 32 | -0.3 units on a scale | Standard Deviation 5.1 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 8 | -0.9 units on a scale | Standard Deviation 1.7 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 2 | -0.7 units on a scale | Standard Deviation 1.9 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 36 | -0.9 units on a scale | Standard Deviation 1.8 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 6 | -0.8 units on a scale | Standard Deviation 1.9 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | End of combined treatment period | -0.4 units on a scale | Standard Deviation 4.2 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 40 | -1.0 units on a scale | Standard Deviation 2 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 4 | -0.9 units on a scale | Standard Deviation 1.7 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 16 | -0.9 units on a scale | Standard Deviation 1.6 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 52 | -1.2 units on a scale | Standard Deviation 1.6 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 18 | -1.1 units on a scale | Standard Deviation 1.9 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 14 | -1.1 units on a scale | Standard Deviation 1.4 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 44 | -1.1 units on a scale | Standard Deviation 1.8 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 20 | -0.9 units on a scale | Standard Deviation 1.8 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 13 | -1.1 units on a scale | Standard Deviation 1.5 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 3 | -0.7 units on a scale | Standard Deviation 1.8 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 24 | -0.9 units on a scale | Standard Deviation 2.1 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 12 | -1.0 units on a scale | Standard Deviation 1.7 |
| FK949E 300 mg | Change From Baseline in YMRS (Combined Treatment Period I and II) | Week 1 | -0.6 units on a scale | Standard Deviation 2.1 |
Secondary
Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)
The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal.
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 2 | -0.2 units on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 6 | -0.3 units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 4 | -0.4 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 1 | -0.1 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | End of Treatment Period 1 | -0.2 units on a scale | Standard Deviation 2.1 |
| Placebo | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 8 | -0.4 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 3 | -0.1 units on a scale | Standard Deviation 1.9 |
| FK949E 150 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 4 | -1.3 units on a scale | Standard Deviation 2 |
| FK949E 150 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 1 | -0.6 units on a scale | Standard Deviation 1.8 |
| FK949E 150 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 2 | -1.0 units on a scale | Standard Deviation 1.5 |
| FK949E 150 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 3 | -1.2 units on a scale | Standard Deviation 1.7 |
| FK949E 150 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 6 | -1.4 units on a scale | Standard Deviation 2.1 |
| FK949E 150 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 8 | -1.7 units on a scale | Standard Deviation 2.3 |
| FK949E 150 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | End of Treatment Period 1 | -1.6 units on a scale | Standard Deviation 2.3 |
| FK949E 300 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 6 | -0.8 units on a scale | Standard Deviation 1.9 |
| FK949E 300 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 2 | -0.7 units on a scale | Standard Deviation 1.9 |
| FK949E 300 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | End of Treatment Period 1 | -0.8 units on a scale | Standard Deviation 2 |
| FK949E 300 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 8 | -0.9 units on a scale | Standard Deviation 1.7 |
| FK949E 300 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 4 | -0.9 units on a scale | Standard Deviation 1.7 |
| FK949E 300 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 3 | -0.7 units on a scale | Standard Deviation 1.8 |
| FK949E 300 mg | Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I) | Week 1 | -0.6 units on a scale | Standard Deviation 2.1 |
Secondary
Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)
The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.
Time frame: Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 1 | 4.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 8 | 4.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 4 | 4.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 6 | 4.0 units on a scale | Standard Deviation 0.3 |
| Placebo | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 2 | 4.0 units on a scale | Standard Deviation 0.2 |
| Placebo | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 3 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 4 | 4.0 units on a scale | Standard Deviation 0.4 |
| FK949E 150 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 1 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 2 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 3 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 6 | 3.9 units on a scale | Standard Deviation 0.2 |
| FK949E 150 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 8 | 3.9 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 6 | 4.0 units on a scale | Standard Deviation 0.3 |
| FK949E 300 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 3 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 1 | 4.0 units on a scale | Standard Deviation 0.1 |
| FK949E 300 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 8 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 4 | 4.0 units on a scale | Standard Deviation 0.2 |
| FK949E 300 mg | Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I) | Week 2 | 4.0 units on a scale | Standard Deviation 0.3 |
Secondary
Number of Participants With Adverse Events (Combined Treatment Period I and II)
An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups.
Time frame: Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E & FK949E 300 mg / FK949E groups, from week 0 to week 52)
Population: SAF for combined Treatment Periods I and II, which included participants who were treated with FK949E at least one time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related AEs | 100 Participants |
| Placebo | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related SAEs | 0 Participants |
| Placebo | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Serious AEs | 1 Participants |
| Placebo | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Any AE | 110 Participants |
| Placebo | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related AEs that caused study drug discont | 13 Participants |
| Placebo | Number of Participants With Adverse Events (Combined Treatment Period I and II) | AEs that caused study drug discontimuation | 15 Participants |
| Placebo | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Deaths | 0 Participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Serious AEs | 4 Participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Any AE | 63 Participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related AEs | 60 Participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Deaths | 0 Participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related SAEs | 2 Participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | AEs that caused study drug discontimuation | 15 Participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related AEs that caused study drug discont | 11 Participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related SAEs | 2 Participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related AEs | 159 Participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Drug-related AEs that caused study drug discont | 39 Participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | AEs that caused study drug discontimuation | 51 Participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Serious AEs | 5 Participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Deaths | 0 Participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Combined Treatment Period I and II) | Any AE | 171 Participants |
Secondary
Number of Participants With Adverse Events (Treatment Period I)
An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.
Time frame: Up to 8 weeks
Population: Safety Analysis Set (SAF), which included participants who received at least one dose of study drug for Treatment Period I.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (Treatment Period I) | Any AE | 81 participants |
| Placebo | Number of Participants With Adverse Events (Treatment Period I) | Drug-related AEs | 52 participants |
| Placebo | Number of Participants With Adverse Events (Treatment Period I) | Deaths | 1 participants |
| Placebo | Number of Participants With Adverse Events (Treatment Period I) | Serious AEs | 2 participants |
| Placebo | Number of Participants With Adverse Events (Treatment Period I) | AEs that caused study drug discontimuation | 16 participants |
| Placebo | Number of Participants With Adverse Events (Treatment Period I) | Drug-related SAEs | 0 participants |
| Placebo | Number of Participants With Adverse Events (Treatment Period I) | Drug-related AEs that caused study drug discont. | 11 participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Treatment Period I) | Deaths | 0 participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Treatment Period I) | Serious AEs | 1 participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Treatment Period I) | Drug-related AEs that caused study drug discont. | 5 participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Treatment Period I) | AEs that caused study drug discontimuation | 6 participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Treatment Period I) | Any AE | 55 participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Treatment Period I) | Drug-related SAEs | 0 participants |
| FK949E 150 mg | Number of Participants With Adverse Events (Treatment Period I) | Drug-related AEs | 50 participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Treatment Period I) | Drug-related AEs | 133 participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Treatment Period I) | Deaths | 0 participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Treatment Period I) | AEs that caused study drug discontimuation | 27 participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Treatment Period I) | Drug-related AEs that caused study drug discont. | 23 participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Treatment Period I) | Drug-related SAEs | 0 participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Treatment Period I) | Serious AEs | 0 participants |
| FK949E 300 mg | Number of Participants With Adverse Events (Treatment Period I) | Any AE | 149 participants |
Secondary
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.
Time frame: Weeks 4, 8
Population: SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Wish to be dead | 32 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Wish to be dead | 19 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal intent w/ plan | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal intent (w/o plan) | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal thoughts | 6 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal intent (w/o plan) | 2 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal thoughts w/ method | 3 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal thoughts w/ method | 4 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal intent w/ plan | 1 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Endf of Period I: Suicidal thoughts w/ method | 7 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal intent (w/o plan) | 1 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal thoughts | 10 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal thoughts | 13 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal intent w/ plan | 1 participants |
| Placebo | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Wish to be dead | 39 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Wish to be dead | 6 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Wish to be dead | 14 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal thoughts | 3 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal thoughts w/ method | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal intent (w/o plan) | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal intent w/ plan | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal thoughts | 2 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal thoughts w/ method | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal intent (w/o plan) | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal intent w/ plan | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Wish to be dead | 8 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal thoughts | 3 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Endf of Period I: Suicidal thoughts w/ method | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal intent (w/o plan) | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal intent w/ plan | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal intent w/ plan | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal intent w/ plan | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal intent w/ plan | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Wish to be dead | 26 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal intent (w/o plan) | 1 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal intent (w/o plan) | 1 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | End of Period I: Suicidal thoughts | 9 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal thoughts | 2 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal thoughts w/ method | 5 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal thoughts w/ method | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Wish to be dead | 15 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Wish to be dead | 34 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 8: Suicidal intent (w/o plan) | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Endf of Period I: Suicidal thoughts w/ method | 7 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I) | Week 4: Suicidal thoughts | 10 participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II) | Week 20 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Endof combined treatment period | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 48 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Endof combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Endof combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 40 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 24 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | End of combined treatment period | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 36 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 28 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 48 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 32 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 16 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 52 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 44 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 20 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 32 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 44 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 48 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 52 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 4 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 32 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 24 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 8 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II | Week 20 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 16 | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 20 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 40 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 12 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 4 | 2 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 48 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 8 | 2 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 36 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II) | Week 20 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | End of combined treatment period | 2 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 28 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 48 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 24 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II) | Week 20 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 28 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 32 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 24 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II) | Week 20 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).
Time frame: Weeks 4, 8
Population: SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Suicide attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Suicide attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Suicide attempt | 2 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Self-injury w/o intent | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Interrupted attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Completed suicide | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Discontinued attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Completed suicide | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Suicidal behavior | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Interrupted attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Preliminary act to suicide | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Preliminary act to suicide | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Preliminary act to suicide | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Suicidal behavior | 2 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Interrupted attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Suicidal behavior | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Discontinued attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Discontinued attempt | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Completed suicide | 0 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Self-injury w/o intent | 1 participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Self-injury w/o intent | 1 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Preliminary act to suicide | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Suicide attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Self-injury w/o intent | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Discontinued attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Interrupted attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Preliminary act to suicide | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Suicidal behavior | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Completed suicide | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Suicide attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Self-injury w/o intent | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Discontinued attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Interrupted attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Preliminary act to suicide | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Suicidal behavior | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Completed suicide | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Suicide attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Self-injury w/o intent | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Discontinued attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Interrupted attempt | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Suicidal behavior | 0 participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Completed suicide | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Suicide attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Self-injury w/o intent | 2 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Suicide attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Completed suicide | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Completed suicide | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Self-injury w/o intent | 2 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Suicidal behavior | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Suicidal behavior | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Discontinued attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Preliminary act to suicide | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Suicide attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Interrupted attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Interrupted attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Interrupted attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Preliminary act to suicide | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Discontinued attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 4: Discontinued attempt | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Suicidal behavior | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Self-injury w/o intent | 2 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | End of Period I: Preliminary act to suicide | 0 participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I) | Week 8: Completed suicide | 0 participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | End of combined treatment period | 2 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 16 | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 32 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | End of combined treatment period | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II) | Week 8 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | End of combined treatment period | 2 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 16 | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 32 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 48 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 52 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | End of combined treatment period | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | End of combined treatment period | 4 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 16 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 24 | 2 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 4 | 1 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II) | Week 8 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 40 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 24 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | End of combined treatment period | 2 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 36 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 28 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 48 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 32 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 16 | 2 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 52 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 44 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 20 | 0 particpants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 12 | 4 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 4 | 3 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 8 | 2 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 12 | 2 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 16 | 2 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 20 | 2 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 24 | 1 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 28 | 1 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 32 | 0 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 36 | 1 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 40 | 2 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 44 | 0 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 48 | 1 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 52 | 1 particpants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | End of combined treatment period | 2 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | End of combined treatment period | 14 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 40 | 1 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 16 | 5 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 52 | 0 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 44 | 2 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 12 | 1 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 4 | 10 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 28 | 2 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 48 | 2 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 32 | 0 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 24 | 2 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 8 | 2 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 36 | 2 particpants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II) | Week 20 | 0 particpants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 12 | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | End of combined treatment period | 2 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 16 | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 32 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 4 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 8 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 16 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 20 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 24 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 36 | 0 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 40 | 2 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 48 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 52 | 1 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | End of combined treatment period | 4 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 48 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 36 | 2 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 12 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | End of combined treatment period | 12 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 16 | 4 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 40 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 44 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 24 | 2 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 4 | 5 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 28 | 0 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II) | Week 8 | 0 Participants |
Secondary
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)
The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
Population: SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 40 | 3 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 24 | 5 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | End of combined treatment period | 6 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 36 | 2 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 28 | 4 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 48 | 3 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 32 | 6 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 16 | 9 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 52 | 1 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 44 | 3 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 20 | 6 Participants |
| Placebo | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 12 | 17 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 4 | 14 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 8 | 6 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 12 | 9 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 16 | 8 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 20 | 8 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 24 | 5 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 28 | 4 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 32 | 4 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 36 | 4 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 40 | 4 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 44 | 3 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 48 | 4 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 52 | 4 Participants |
| FK949E 150 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | End of combined treatment period | 11 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | End of combined treatment period | 26 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 40 | 6 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 16 | 22 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 52 | 3 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 44 | 7 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 12 | 21 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 4 | 34 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 28 | 8 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 48 | 7 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 32 | 9 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 24 | 8 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 8 | 15 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 36 | 8 Participants |
| FK949E 300 mg | Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II) | Week 20 | 12 Participants |
Secondary
Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)
A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | End of combined treatment period | 53 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 28 | 44 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 44 | 41 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 20 | 40 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 52 | 40 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 16 | 30 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 14 | 20 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 36 | 36 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 3 | 27 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 2 | 22 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 4 | 32 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 6 | 39 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 8 | 35 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 10 | 35 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 12 | 32 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 14 | 35 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 16 | 30 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 20 | 32 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 28 | 32 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 36 | 29 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 44 | 25 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 52 | 25 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | End of combined treatment period | 43 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 1 | 7 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 52 | 58 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 28 | 73 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 6 | 63 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 1 | 14 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 36 | 61 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 4 | 61 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 2 | 39 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 44 | 61 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 14 | 78 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 12 | 77 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 3 | 50 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 16 | 80 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 10 | 77 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | End of combined treatment period | 95 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 20 | 75 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Combined Treatment Period I and II) | Week 8 | 73 Participants |
Secondary
Number of Participants With HAM-D17 Response (Treatment Period I)
A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 1 | 10 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 2 | 29 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 3 | 41 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 4 | 54 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 6 | 63 Participants |
| Placebo | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 8 | 68 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 8 | 41 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 1 | 7 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 4 | 35 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 6 | 44 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 2 | 22 Participants |
| FK949E 150 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 3 | 30 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 2 | 42 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 3 | 52 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 8 | 78 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 4 | 64 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 1 | 14 Participants |
| FK949E 300 mg | Number of Participants With HAM-D17 Response (Treatment Period I) | Week 6 | 66 Participants |
Secondary
Number of Participants With MADRS Remission (Combined Treatment Period I and II)
MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 24 | 67 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 40 | 60 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 20 | 64 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 48 | 55 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 18 | 69 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 36 | 56 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 16 | 52 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 12 | 41 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 44 | 54 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 14 | 51 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 13 | 48 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 32 | 55 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | End of combined treatment period | 75 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 28 | 62 Participants |
| Placebo | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 52 | 54 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 28 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 52 | 26 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | End of combined treatment period | 38 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 1 | 4 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 2 | 11 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 3 | 20 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 4 | 19 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 6 | 24 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 8 | 25 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 10 | 24 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 12 | 20 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 13 | 24 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 14 | 24 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 16 | 20 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 18 | 23 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 20 | 24 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 24 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 48 | 24 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 32 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 36 | 27 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 40 | 26 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 44 | 24 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 6 | 56 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | End of combined treatment period | 82 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 20 | 64 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 4 | 45 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 44 | 54 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 24 | 65 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 3 | 36 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 40 | 55 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 28 | 64 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 2 | 25 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 52 | 51 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 32 | 58 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 13 | 58 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 12 | 58 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 1 | 12 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 14 | 60 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 10 | 61 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 48 | 51 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 16 | 60 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 8 | 61 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 36 | 53 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Combined Treatment Period I and II) | Week 18 | 68 Participants |
Secondary
Number of Participants With MADRS Remission (Treatment Period I)
MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
Time frame: Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With MADRS Remission (Treatment Period I) | Week 1 | 4 Participants |
| Placebo | Number of Participants With MADRS Remission (Treatment Period I) | Week 2 | 9 Participants |
| Placebo | Number of Participants With MADRS Remission (Treatment Period I) | Week 3 | 26 Participants |
| Placebo | Number of Participants With MADRS Remission (Treatment Period I) | Week 4 | 31 Participants |
| Placebo | Number of Participants With MADRS Remission (Treatment Period I) | Week 6 | 39 Participants |
| Placebo | Number of Participants With MADRS Remission (Treatment Period I) | Week 8 | 47 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 8 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 1 | 4 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 4 | 21 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 6 | 27 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 2 | 12 Participants |
| FK949E 150 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 3 | 21 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 2 | 28 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 3 | 39 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 8 | 68 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 4 | 49 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 1 | 12 Participants |
| FK949E 300 mg | Number of Participants With MADRS Remission (Treatment Period I) | Week 6 | 60 Participants |
Secondary
Number of Participants With MADRS Response (Combined Treatment Period I and II)
A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
Time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 44 | 42 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 48 | 38 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 18 | 48 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 36 | 43 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 32 | 43 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 20 | 47 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 13 | 8 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 28 | 48 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 24 | 48 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | End of combined treatment period | 57 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 14 | 26 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 40 | 47 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 52 | 41 Participants |
| Placebo | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 16 | 31 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 32 | 31 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 2 | 16 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 3 | 23 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 4 | 25 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 13 | 32 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 14 | 30 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 16 | 26 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 18 | 30 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 20 | 30 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 24 | 31 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 28 | 34 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 1 | 6 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 48 | 29 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 52 | 27 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | End of combined treatment period | 42 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 36 | 30 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 40 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 44 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 6 | 30 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 8 | 27 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 10 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 12 | 22 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 52 | 57 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 13 | 65 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 6 | 66 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | End of combined treatment period | 89 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 4 | 58 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 1 | 15 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 36 | 61 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 3 | 49 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 8 | 73 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 40 | 62 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 24 | 74 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 20 | 73 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 2 | 37 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 28 | 71 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 18 | 78 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 12 | 68 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 32 | 65 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 16 | 67 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 44 | 61 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 48 | 57 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 14 | 66 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Combined Treatment Period I and II) | Week 10 | 71 Participants |
Secondary
Number of Participants With MADRS Response (Treatment Period I)
A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
Population: FAS; LOCF imputation method was used for all time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With MADRS Response (Treatment Period I) | Week 6 | 54 Participants |
| Placebo | Number of Participants With MADRS Response (Treatment Period I) | Week 2 | 13 Participants |
| Placebo | Number of Participants With MADRS Response (Treatment Period I) | Week 4 | 47 Participants |
| Placebo | Number of Participants With MADRS Response (Treatment Period I) | Week 3 | 36 Participants |
| Placebo | Number of Participants With MADRS Response (Treatment Period I) | Week 1 | 4 Participants |
| Placebo | Number of Participants With MADRS Response (Treatment Period I) | Week 8 | 63 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 8 | 32 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 4 | 28 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 1 | 6 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 2 | 17 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 3 | 25 Participants |
| FK949E 150 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 6 | 34 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 4 | 62 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 1 | 15 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 8 | 79 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 6 | 70 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 2 | 41 Participants |
| FK949E 300 mg | Number of Participants With MADRS Response (Treatment Period I) | Week 3 | 52 Participants |