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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111632 | Other Identifier | JAPIC |
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To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-34712 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-34712 | Drug | orally administered once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment. | From Baseline up to 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS Total score ranged from 7 (best possible outcome) to 210 (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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32297486 | Derived | Ishigooka J, Usami T, Iwashita S, Kojima Y, Matsuo S. Post-hoc analysis investigating the safety and efficacy of brexpiprazole in Japanese patients with schizophrenia who were switched from other antipsychotics in a long-term study (Secondary Publication). Neuropsychopharmacol Rep. 2020 Jun;40(2):122-129. doi: 10.1002/npr2.12107. Epub 2020 Apr 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Subjects | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in this trial |
| FG001 | Rollover Subjects | Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | New Subjects | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in this trial |
| BG001 | Rollover Subjects |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Participants With Adverse Events | A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment. | Safety sample included those participants who had treated IMP. | Posted | Count of Participants | Participants | From Baseline up to 52 Weeks |
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Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days after the completion of the treatment period (52 weeks).
Incidence of Non-Serious TEAE of at Least 5% in Any Group by System Organ Class and MedDRA Preferred Term
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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 | New Subjects | Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in this trial |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Ver. 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | 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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| From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
| Mean Change From Baseline in PANSS Positive Subscale Score | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In PANSS positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
| Mean Change From Baseline in PANSS Negative Subscale Score | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In PANSS negative subscale the severity was rated for the following 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). | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
| Mean Change From Baseline 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. | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
| Mean Clinical Global Impression - Global Improvement(CGI-I) | 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 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. | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
| Physician Decision |
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| Withdrawal by Subject |
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| Lack of Efficacy |
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Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS Total score ranged from 7 (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 | Mean | Standard Deviation | units on a scale | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
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| Secondary | Mean Change From Baseline in PANSS Positive Subscale Score | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In PANSS positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, 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 | Mean | Standard Deviation | units on a scale | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
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| Secondary | Mean Change From Baseline in PANSS Negative Subscale Score | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In PANSS negative subscale the severity was rated for the following 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). | 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 | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
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| Secondary | Mean Change From Baseline 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 | Mean | Standard Deviation | units on a scale | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
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| Secondary | Mean Clinical Global Impression - Global Improvement(CGI-I) | 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 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 | From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF) |
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| 0 |
| 183 |
| 19 |
| 183 |
| 112 |
| 183 |
| EG001 | Rollover Subjects | Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-10-002); all received 1-4 mg of daily treatment with open label brexpiprazole in this trial | 0 | 98 | 18 | 98 | 50 | 98 |
| Meningitis aseptic | Infections and infestations | MedDRA Ver. 16.0 |
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| Heat illness | Injury, poisoning and procedural complications | MedDRA Ver. 16.0 |
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| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA Ver. 16.0 |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 16.0 |
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| Akathisia | Nervous system disorders | MedDRA Ver. 16.0 |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA Ver. 16.0 |
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| Schizophrenia | Psychiatric disorders | MedDRA Ver. 16.0 |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 16.0 |
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| Weight increased | Investigations | MedDRA Ver. 16.0 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 16.0 |
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| Akathisia | Nervous system disorders | MedDRA Ver. 16.0 |
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| Headache | Nervous system disorders | MedDRA Ver. 16.0 |
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| Somnolence | Nervous system disorders | MedDRA Ver. 16.0 |
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| Tremor | Nervous system disorders | MedDRA Ver. 16.0 |
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| Schizophrenia | Psychiatric disorders | MedDRA Ver. 16.0 |
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| Insomnia | Psychiatric disorders | MedDRA Ver. 16.0 |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 16.0 |
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| Last Visit |
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| Last Visit |
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| Last Visit |
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| Last Visit |
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| Last Visit |
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