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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111631 | Other Identifier | JAPIC |
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To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Experimental |
| |
| Mid dose | Experimental |
| |
| Low dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-34712 | Drug | orally administered once daily |
| |
| OPC-34712 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score. | PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| kyoji Imaoka, Operating Officer | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto Region | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole 1mg | Brexpiprazole 1 mg tablet once daily for 6 weeks. |
| FG001 | Brexpiprazole 2mg | Brexpiprazole 2 mg tablet once daily for 6 weeks. |
| FG002 | Brexpiprazole 4mg | Brexpiprazole 4 mg tablet once daily for 6 weeks. |
| FG003 | Placebo | Placebo tablet once daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole 1mg | Brexpiprazole 1 mg tablet once daily for 6 weeks. |
| BG001 | Brexpiprazole 2mg | Brexpiprazole 2 mg tablet once daily for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). | Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
|
Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the last dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brexpiprazole 1mg | Brexpiprazole 1 mg tablet once daily for 6 weeks. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Ver. 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 16.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | CL_OPCJ_RDA_Team@otsuka.jp |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Drug |
orally administered once daily |
|
| OPC-34712 | Drug | orally administered once daily |
|
| Placebo | Drug | orally administered once daily |
|
| Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
| Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
| Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S) | Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
| Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6. | The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
| Withdrawal Criteria |
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| Physician Decision |
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| Withdrawal by Subject |
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| Protocol Violation |
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| Lack of Efficacy |
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| BG002 | Brexpiprazole 4mg | Brexpiprazole 4 mg tablet once daily for 6 weeks. |
| BG003 | Placebo | Placebo tablet once daily for 6 weeks. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Brexpiprazole 1 mg tablet once daily for 6 weeks.
| OG001 | Brexpiprazole 2mg | Brexpiprazole 2 mg tablet once daily for 6 weeks. |
| OG002 | Brexpiprazole 4mg | Brexpiprazole 4 mg tablet once daily for 6 weeks. |
| OG003 | Placebo | Placebo tablet once daily for 6 weeks. |
|
|
| Secondary | Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score. | PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). | Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
|
|
|
| Secondary | Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). | EEfficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
|
|
|
| Secondary | Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S) | Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. | Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
|
|
|
| Secondary | Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6. | The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. | Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |
|
|
|
| 115 |
| 8 |
| 115 |
| 49 |
| 115 |
| EG001 | Brexpiprazole 2mg | Brexpiprazole 2 mg tablet once daily for 6 weeks. | 0 | 114 | 5 | 114 | 46 | 114 |
| EG002 | Brexpiprazole 4mg | Brexpiprazole 4 mg tablet once daily for 6 weeks. | 0 | 113 | 5 | 113 | 49 | 113 |
| EG003 | Placebo | Placebo tablet once daily for 6 weeks. | 0 | 116 | 5 | 116 | 56 | 116 |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA Ver. 16.0 |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Ver. 16.0 |
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| Electroencephalogram abnormal | Investigations | MedDRA Ver. 16.0 |
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| Schizophrenia | Psychiatric disorders | MedDRA Ver. 16.0 |
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| Psychiatric symptom | Psychiatric disorders | MedDRA Ver. 16.0 |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 16.0 |
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| Vomiting | Gastrointestinal disorders | MedDRA Ver. 16.0 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 16.0 |
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| Nausea | Gastrointestinal disorders | MedDRA Ver. 16.0 |
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| Dental caries | Gastrointestinal disorders | MedDRA Ver. 16.0 |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 16.0 |
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| Blood prolactin increased | Investigations | MedDRA Ver. 16.0 |
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| Headache | Nervous system disorders | MedDRA Ver. 16.0 |
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| Akathisia | Nervous system disorders | MedDRA Ver. 16.0 |
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| Schizophrenia | Psychiatric disorders | MedDRA Ver. 16.0 |
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