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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole | Experimental | Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally |
|
| Aripiprazole | Experimental | Aripiprazole - Up to 20 mg/day, once daily dose, tablets, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cognitive Test Battery Composite Score | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junichi Hashimoto, PhD | Otsuka Pharmaceutical Co., Ltd Japan (OPCJ) | Study Director |
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The trial consisted of a 2- to 14-day screening phase, a 6-week treatment phase, and a 30-day follow-up phase.
The trial was conducted in 97 participants at 19 trial sites in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole | Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6. |
| FG001 | Aripiprazole | Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole | Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6. |
| BG001 | Arpiprazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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). | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a mixed model repeated measures (MMRM) analysis with an unstructured variance covariance structure. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 6 |
|
Adverse events were reported from the signing of informed consent throughout the 6-week treatment period until the follow-up visit 30 days (+2) after the last dose of study medication.
Participants with adverse events were counted only once towards the total.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brexpiprazole | Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute hepatitis B | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development and Commercialization, Inc. | 800 562-3974 |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
Not provided
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
Not provided
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Not provided
Not provided
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Not provided
| Aripiprazole |
| Drug |
Up to 20 mg/day, once daily dose, tablets, orally |
|
| Baseline to Week 6 |
| Change From Baseline in Cognitive Test Battery of Early Phase Battery Score | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task. | Baseline to Week 6 |
| Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML) | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | Baseline to Week 6 |
| Change From Baseline in Cognitive Test Battery Scores of Detection Task | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | Baseline to Week 6 |
| Change From Baseline in Cognitive Test Battery Scores of Identification Task | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | Baseline to Week 6 |
| Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | Baseline to Week 6 |
| Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score | The severity of illness for each participant was rated using the CGI-S. 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 to Week 6 |
| Mean Change in Clinical Global Impression-Improvement (CGI-I) 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 to Week 6 |
| Response Rate by Study Week | The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved). | Baseline to Week 6 |
| Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score | The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject's quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 "not well at all" to 5 "very well". The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant. | Baseline to Week 6 |
| Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score | The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait. | Baseline to Week 6 |
| Met Withdrawal Criteria |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Brexpiprazole |
Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6. |
| OG001 | Aripiprazole | Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6. |
|
|
|
| Secondary | Change From Baseline in Cognitive Test Battery Composite Score | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure. | Posted | Least Squares Mean | Standard Error | z-score | Baseline to Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Cognitive Test Battery of Early Phase Battery Score | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure. | Posted | Least Squares Mean | Standard Error | z-score | Baseline to Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML) | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | z-score | Baseline to Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Cognitive Test Battery Scores of Detection Task | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure. | Posted | Least Squares Mean | Standard Error | z-score | Baseline to Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Cognitive Test Battery Scores of Identification Task | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure. | Posted | Least Squares Mean | Standard Error | z-score | Baseline to Week 6 |
|
|
|
|
| Secondary | Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task | The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = - 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure. | Posted | Least Squares Mean | Standard Error | z-score | Baseline to Week 6 |
|
|
|
|
| Secondary | Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score | The severity of illness for each participant was rated using the CGI-S. 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. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 6 |
|
|
|
|
| Secondary | Mean Change in Clinical Global Impression-Improvement (CGI-I) 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. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 6 |
|
|
|
| Secondary | Response Rate by Study Week | The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved). | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset. | Posted | Number | percentage of participants | Baseline to Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score | The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject's quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 "not well at all" to 5 "very well". The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline to Week 6 |
|
|
|
|
| Secondary | Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score | The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait. | All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline to Week 6 |
|
|
|
|
| 3 |
| 64 |
| 36 |
| 64 |
| EG001 | Aripiprazole | Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6. | 1 | 33 | 21 | 33 |
| Convulsion | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Presynscope | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole. |
| Mixed Models Analysis |
Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction. |
| 0.7623 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole. |
| Mixed Models Analysis |
Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction. |
| 0.2176 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole. |
| Mixed Models Analysis |
Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction. |
| 0.3781 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole. |
| Mixed Models Analysis |
Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction. |
| 0.2802 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole. |
| Mixed Models Analysis |
Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction. |
| 0.4848 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole. |
| Mixed Models Analysis |
Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction. |
| 0.9928 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.
| Mixed Models Analysis |
Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction. |
| <0.0001 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole. |
| Mixed Models Analysis |
The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons. |
| <0.0001 |
| 2-Sided |
| No |
| Superiority or Other |
Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole. |
| ANCOVA |
The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons. |
| 0.9716 |
| 2-Sided |
| No |
| Superiority or Other |