Major Depressive Disorder
Conditions
Keywords
patients, FK949E
Brief summary
In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.
Interventions
DRUGquetiapine extended release (XR)
Extended release tablets
DRUGPlacebo
matching tablets
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 major depressive disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) with the use of the Mini-International Neuropsychiatric Interview (M.I.N.I.) * Documented appropriate treatment history (i.e., lack of response to treatment at labeled dosage for at least 4 weeks) for the current major depression episode with an antidepressant other than that used concomitantly with the study drug * 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
Exclusion criteria
* Concurrent or previous history of DSM-IV-TR Axis I disorders, except major depressive 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 duration of the current major depression episode is shorter than 4 weeks or longer than 24 months at informed consent * History of dependence of substances other than caffeine and nicotine or history of abuse or dependence of alcohol * The HAM-D17 suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion * Concurrent or previous history of diabetes mellitus. HbA1c levels of 6.1% (Japan Diabetes Society values) or more within the past 2 months * Electroconvulsive therapy within the last 62 days before primary registration (within the last 90 days before secondary registration) * Treatment with a depot antipsychotic within the last 28 days * Documented or suspected (to be a carrier of) conditions such as renal failure, hepatic failure, serious cardiac disease (or current use of antiarrhythmic drugs), hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS) * 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 subinvestigator * Concurrence of hypotension (defined as a systolic blood pressure of less than 100 mmHg at primary registration) or orthostatic hypotension * Concurrence of malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug * Concurrent or previous history of cerebrovascular disease or transient ischemic attack (TIA) * Known hypersensitivity to quetiapine or any component of FK949E tablets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline and Week 6 | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) | Baseline and Week 6 | The 17-item Hamilton Depression Scale (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 range is from 0 to 52 where a higher score indicates a greater depressive state. |
| Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) | Baseline and Week 6 | The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened. Improvement is defined as a score of 1 or 2. |
| Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Baseline and Week 6 | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status. |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) | Baseline and Week 6 | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality. |
| Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Up to 8 weeks | An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was 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 were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo tablets once daily before bedtime for 7 weeks. | 44 |
| Quetiapine 50 mg Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks. | 44 |
| Quetiapine 150 mg After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week. | 41 |
| Quetiapine 300 mg After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week. | 43 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 6 | 4 |
| Overall Study | Exacerbation of Target Disease | 1 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 1 |
| Overall Study | Met Exclusion Criteria | 0 | 0 | 1 | 0 |
| Overall Study | Study Site Withdrawal | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Quetiapine 50 mg | Quetiapine 150 mg | Quetiapine 300 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 11.2 | 39.0 years STANDARD_DEVIATION 9.5 | 35.2 years STANDARD_DEVIATION 8.6 | 37.3 years STANDARD_DEVIATION 9.7 | 37.9 years STANDARD_DEVIATION 9.9 |
| Hamilton Depression Scale 17-Item (HAM D17) | 22.6 units on a scale STANDARD_DEVIATION 2.3 | 22.6 units on a scale STANDARD_DEVIATION 2.4 | 23.3 units on a scale STANDARD_DEVIATION 3 | 22.9 units on a scale STANDARD_DEVIATION 2.5 | 22.8 units on a scale STANDARD_DEVIATION 2.6 |
| Montgomery Åsberg Depression Rating Scale (MADRS) | 28.5 units on a scale STANDARD_DEVIATION 5.1 | 28.7 units on a scale STANDARD_DEVIATION 5.9 | 29.0 units on a scale STANDARD_DEVIATION 5.4 | 29.3 units on a scale STANDARD_DEVIATION 5.4 | 28.9 units on a scale STANDARD_DEVIATION 5.4 |
| Region of Enrollment Japan | 44 participants | 44 participants | 41 participants | 43 participants | 172 participants |
| Sex: Female, Male Female | 19 Participants | 15 Participants | 17 Participants | 17 Participants | 68 Participants |
| Sex: Female, Male Male | 25 Participants | 29 Participants | 24 Participants | 26 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 44 | 23 / 44 | 26 / 41 | 28 / 43 |
| serious Total, serious adverse events | 0 / 44 | 1 / 44 | 0 / 41 | 1 / 43 |
Outcome results
Primary
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Time frame: Baseline and Week 6
Population: Full Analysis Set: Participants who met the following requirements: major depressive disorder confirmed at registration; at least one dose of the study drug for the treatment period was administered; and at least one efficacy variable was assessed after the start of treatment. Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -11.5 units on a scale | Standard Error 1.2 |
| Quetiapine 50 mg | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -11.3 units on a scale | Standard Error 1.2 |
| Quetiapine 150 mg | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -12.1 units on a scale | Standard Error 1.2 |
| Quetiapine 300 mg | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -10.3 units on a scale | Standard Error 1.2 |
95% CI: [-3.1, 3.6]
95% CI: [-4, 2.8]
95% CI: [-2.1, 4.6]
Secondary
Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)
The 17-item Hamilton Depression Scale (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 range is from 0 to 52 where a higher score indicates a greater depressive state.
Time frame: Baseline and Week 6
Population: Full analysis set; Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) | -10.1 units on a scale | Standard Deviation 6 |
| Quetiapine 50 mg | Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) | -9.3 units on a scale | Standard Deviation 5.9 |
| Quetiapine 150 mg | Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) | -10.2 units on a scale | Standard Deviation 5.7 |
| Quetiapine 300 mg | Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) | -8.7 units on a scale | Standard Deviation 6.1 |
Secondary
Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status.
Time frame: Baseline and Week 6
Population: Full analysis set with available SF-36 data; LOCF was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Physical Functioning | 2.8 units on a scale | Standard Deviation 13.3 |
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Physical | 8.8 units on a scale | Standard Deviation 24.8 |
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Bodily pain | 4.4 units on a scale | Standard Deviation 21.4 |
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | General Health Perception | 6.3 units on a scale | Standard Deviation 12.3 |
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Vitality | 7.5 units on a scale | Standard Deviation 15.8 |
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Social Functioning | 7.1 units on a scale | Standard Deviation 21.3 |
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Emotional | 9.8 units on a scale | Standard Deviation 29.5 |
| Placebo | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Mental Health | 2.5 units on a scale | Standard Deviation 18.9 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Social Functioning | 6.5 units on a scale | Standard Deviation 27.3 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Vitality | 8.1 units on a scale | Standard Deviation 21.3 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Physical | 1.1 units on a scale | Standard Deviation 28 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Mental Health | 9.7 units on a scale | Standard Deviation 22 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Emotional | 13.8 units on a scale | Standard Deviation 24 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | General Health Perception | 6.0 units on a scale | Standard Deviation 14.8 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Bodily pain | 11.2 units on a scale | Standard Deviation 23.9 |
| Quetiapine 50 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Physical Functioning | 1.4 units on a scale | Standard Deviation 14.3 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Emotional | 11.8 units on a scale | Standard Deviation 27.7 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Bodily pain | 2.5 units on a scale | Standard Deviation 25.2 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | General Health Perception | 4.7 units on a scale | Standard Deviation 16.8 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Vitality | 6.7 units on a scale | Standard Deviation 15.8 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Social Functioning | 7.4 units on a scale | Standard Deviation 25.9 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Mental Health | 8.1 units on a scale | Standard Deviation 16.7 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Physical Functioning | 0.4 units on a scale | Standard Deviation 14.9 |
| Quetiapine 150 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Physical | 7.4 units on a scale | Standard Deviation 31.1 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Bodily pain | -0.5 units on a scale | Standard Deviation 26.9 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | General Health Perception | 8.7 units on a scale | Standard Deviation 13.5 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Physical | 6.1 units on a scale | Standard Deviation 26.2 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Physical Functioning | 1.4 units on a scale | Standard Deviation 12.5 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Vitality | 9.2 units on a scale | Standard Deviation 18.6 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Mental Health | 7.5 units on a scale | Standard Deviation 19.4 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Role Limitations - Emotional | 9.7 units on a scale | Standard Deviation 27.3 |
| Quetiapine 300 mg | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | Social Functioning | 6.0 units on a scale | Standard Deviation 20.3 |
Secondary
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality.
Time frame: Baseline and Week 6
Population: Full analysis set with available PSQI data; LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) | -1.1 units on a scale | Standard Deviation 2.9 |
| Quetiapine 50 mg | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) | -1.8 units on a scale | Standard Deviation 2.7 |
| Quetiapine 150 mg | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) | -1.5 units on a scale | Standard Deviation 2.7 |
| Quetiapine 300 mg | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) | -1.8 units on a scale | Standard Deviation 3 |
Secondary
Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)
The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened. Improvement is defined as a score of 1 or 2.
Time frame: Baseline and Week 6
Population: Full analysis set; Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) | 54.5 percentage of participants |
| Quetiapine 50 mg | Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) | 50.0 percentage of participants |
| Quetiapine 150 mg | Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) | 53.7 percentage of participants |
| Quetiapine 300 mg | Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) | 27.2 percentage of participants |
Secondary
Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests
An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was 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 were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.
Time frame: Up to 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Any adverse event | 25 participants |
| Placebo | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | AE leading to discontinuation | 2 participants |
| Placebo | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related serious adverse event | 0 participants |
| Placebo | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related adverse event | 21 participants |
| Placebo | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related AE leading to discontinuation | 1 participants |
| Placebo | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Deaths | 0 participants |
| Placebo | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Serious adverse event | 0 participants |
| Quetiapine 50 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | AE leading to discontinuation | 2 participants |
| Quetiapine 50 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Serious adverse event | 1 participants |
| Quetiapine 50 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Deaths | 0 participants |
| Quetiapine 50 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related serious adverse event | 1 participants |
| Quetiapine 50 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related AE leading to discontinuation | 2 participants |
| Quetiapine 50 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related adverse event | 24 participants |
| Quetiapine 50 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Any adverse event | 33 participants |
| Quetiapine 150 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Serious adverse event | 0 participants |
| Quetiapine 150 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Any adverse event | 35 participants |
| Quetiapine 150 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related adverse event | 29 participants |
| Quetiapine 150 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Deaths | 0 participants |
| Quetiapine 150 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related serious adverse event | 0 participants |
| Quetiapine 150 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | AE leading to discontinuation | 6 participants |
| Quetiapine 150 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related AE leading to discontinuation | 6 participants |
| Quetiapine 300 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Deaths | 0 participants |
| Quetiapine 300 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related AE leading to discontinuation | 2 participants |
| Quetiapine 300 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | AE leading to discontinuation | 4 participants |
| Quetiapine 300 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related adverse event | 31 participants |
| Quetiapine 300 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Any adverse event | 35 participants |
| Quetiapine 300 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Drug-related serious adverse event | 1 participants |
| Quetiapine 300 mg | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | Serious adverse event | 1 participants |