Bipolar I Disorder
Conditions
Brief summary
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
Detailed description
The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.
Interventions
DRUGSM-13496
Sponsors
Sumitomo Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Patients who completed the D1002001 study ・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns. Patients who did not participate in the D1002001 study * Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study. * Outpatients aged 18 through 74 years at the time of consent * Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but \< 8 episodes in the previous 12 months prior to screening).
Exclusion criteria
* Patients with imminent risk of suicide or injury to self, others, or property. * Patients who are otherwise considered ineligible for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | 28, 52 weeks | The number and percentage of subjects with at least one adverse event and adverse drug reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | Baseline, 52 weeks and each month | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. |
| Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | Baseline, 52 weeks and each month | YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items. |
| Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | Baseline to 52 weeks | The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder. |
Countries
Japan, Lithuania, Malaysia, Philippines, Russia, Slovakia, Taiwan, Ukraine
Participant flow
Pre-assignment details
495 represents the total number of subjects who were treated with study drug.
Participants by arm
| Arm | Count |
|---|---|
| SM-13496 20-120mg once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg | 495 |
| Total | 495 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 59 |
| Overall Study | Lack of Efficacy | 23 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Noncompliance | 3 |
| Overall Study | Other reason | 7 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 58 |
Baseline characteristics
| Characteristic | SM-13496 20-120mg |
|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 12.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 225 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 270 Participants |
| Region of Enrollment Japan | 199 participants |
| Region of Enrollment Lithuania | 9 participants |
| Region of Enrollment Malaysia | 11 participants |
| Region of Enrollment Philippines | 8 participants |
| Region of Enrollment Russia | 129 participants |
| Region of Enrollment Slovakia | 15 participants |
| Region of Enrollment Taiwan | 7 participants |
| Region of Enrollment Ukraine | 117 participants |
| Sex: Female, Male Female | 259 Participants |
| Sex: Female, Male Male | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 495 | 0 / 199 |
| other Total, other adverse events | 250 / 495 | 137 / 199 |
| serious Total, serious adverse events | 19 / 495 | 12 / 199 |
Outcome results
Primary
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
The number and percentage of subjects with at least one adverse event and adverse drug reaction
Time frame: 28, 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | 352 Participants |
| SM-13496 20-120mg (Japan, 52 Weeks) | Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | 169 Participants |
Secondary
Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
Time frame: Baseline, 52 weeks and each month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | -4.4 units on a scale | Standard Deviation 12.09 |
| SM-13496 20-120mg (Japan, 52 Weeks) | Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | 1.1 units on a scale | Standard Deviation 12.58 |
Secondary
Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items.
Time frame: Baseline, 52 weeks and each month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | -1.0 units on a scale | Standard Deviation 4.54 |
| SM-13496 20-120mg (Japan, 52 Weeks) | Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | -2.0 units on a scale | Standard Deviation 6.73 |
Secondary
Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.
Time frame: Baseline to 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | 14 Participants |
| SM-13496 20-120mg (Japan, 52 Weeks) | Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | 18 Participants |