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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002252-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Brexpiprazole | Experimental | Patients randomised to brexpiprazole received 1mg/day on Day 1, 2mg/day on Day 2, 3mg/day on Day 3 (uptitration); the dose could be adjusted from Day 4 onwards to 2, 3, or 4mg/day to optimise the clinical effect and tolerability. |
|
| Quetiapine extended release | Other | Active Reference. Patients randomised to quetiapine received 300mg/day on Day 1, 600mg/day on Days 2 and 3 (uptitration); the dose could be adjusted from Day 4 onwards to 400, 600, or 800mg/day to optimise the clinical effect and tolerability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Once daily as tablets and capsules, orally |
| |
| Brexpiprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in CGI-S Score | The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US009 | Escondido | California | 92025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41849920 | Derived | Correll CU, Yildirim M, Zhang Z, Palma AM, Pham T, Pflug B. Efficacy and safety of brexpiprazole in early-episode schizophrenia: post hoc analysis of Phase 3 clinical trials in adults and adolescents. Psychiatry Res. 2026 Jun;360:117091. doi: 10.1016/j.psychres.2026.117091. Epub 2026 Mar 12. | |
| 40859756 | Derived |
| Label | URL |
|---|---|
| EMA EudraCT Results: 2012-002252-17 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Once daily as tablets and capsules, orally |
| FG001 | Brexpiprazole | Brexpiprazole: 2-4 mg/day, once daily, tablets, orally |
| FG002 | Quetiapine Extended Release | Active Reference Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
all-patients-treated set (APTS)
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Once daily as tablets and capsules, orally |
| BG001 | Brexpiprazole | Brexpiprazole: 2-4 mg/day, once daily, tablets, orally |
| 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 PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. | Full-analysis set (FAS) | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
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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 | Placebo | Placebo: Once daily as tablets and capsules, orally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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| Drug |
2-4 mg/day, once daily, tablets, orally |
|
| Quetiapine extended release | Drug | 400-800 mg/day, once daily, encapsulated tablets, orally |
|
|
| Baseline and Week 6 |
| CGI-I Score at Week 6 | The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. | Week 6 |
| Change From Baseline to Week 6 in PANSS Positive Subscale Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS Negative Subscale Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS Excited Component Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | Baseline and Week 6 |
| Discontinuation Due to Lack of Efficacy During the Study | Discontinuation due to lack of efficacy was based on the primary reason for withdrawal | Baseline to Week 6 |
| Response Rate at Week 6 | The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2 | Baseline and Week 6 |
| Change From Baseline to Week 6 in PSP Total Score | The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance. | Baseline and Week 6 |
| PSP Functional Remission Rate at Week 6 | The PSP functional remission rate was defined as a PSP total score ≥71 | Week 6 |
| PSP Functional Response Rate at Week 6 | The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score | Week 6 |
| PSP Domain D: Disturbing and Aggressive Behaviours at Week 6 | PSP domain D: disturbing and aggressive behaviours were categorised as "aggressive" (corresponding to mild, manifest, marked, severe, or very severe) or "nonaggressive" (corresponding to absent) | Week 6 |
| Ismail Z, Kapadia S, Palma AM, Yildirim M, Farovik A. Brexpiprazole for anxiety symptoms in schizophrenia: a pooled analysis of short- and long-term trials. Curr Med Res Opin. 2025 Aug;41(8):1535-1548. doi: 10.1080/03007995.2025.2552286. Epub 2025 Sep 11. |
| 39749727 | Derived | Ismail Z, Meehan SR, Farovik A, Kapadia S, Palma AM, Zhang Z, McIntyre RS. Effects of brexpiprazole on patient life engagement in schizophrenia: post hoc analysis of Positive and Negative Syndrome Scale data. Curr Med Res Opin. 2025 Jan;41(1):145-153. doi: 10.1080/03007995.2024.2440059. Epub 2025 Jan 3. |
| 35235720 | Derived | Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793. |
| 34901863 | Derived | Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan. |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Administrative or other reasons |
|
| BG002 | Quetiapine Extended Release | Active Reference Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time since schizophrenia diagnosis (years) | Mean | Standard Deviation | years |
|
| Time since first antipsychotic treatment (years) | Mean | Standard Deviation | years |
|
| PANSS total score | The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. PANSS total score is reported for the full analysis set (FAS); PBO=159, Brex=150, Que=150, and no total value was summarised for reporting | Mean | Standard Deviation | units on a scale |
|
| CGI-S Score | The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). CGI-S score is reported for the full analysis set (FAS); PBO=159, Brex=150, Que=150, and no total value was summarised for reporting | Mean | Standard Deviation | units on a scale |
|
| OG002 | Quetiapine Extended Release | Active Reference Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally |
|
|
|
| Secondary | Change From Baseline to Week 6 in CGI-S Score | The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | CGI-I Score at Week 6 | The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. | FAS | Posted | Mean | Standard Error | units on a scale | Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Positive Subscale Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Negative Subscale Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Excited Component Score | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression | The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Discontinuation Due to Lack of Efficacy During the Study | Discontinuation due to lack of efficacy was based on the primary reason for withdrawal | APTS | Posted | Number | percentage of patients | Baseline to Week 6 |
|
|
|
| Secondary | Response Rate at Week 6 | The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2 | FAS (last assessment) | Posted | Number | percentage of responders | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline to Week 6 in PSP Total Score | The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance. | FAS. PSP was collected at Baseline, Day 21 and Day 42 only, due to the windowing only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | PSP Functional Remission Rate at Week 6 | The PSP functional remission rate was defined as a PSP total score ≥71 | FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS. | Posted | Number | percentage of remitters | Week 6 |
|
|
|
| Secondary | PSP Functional Response Rate at Week 6 | The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score | FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS. | Posted | Number | percentage of responders | Week 6 |
|
|
|
| Secondary | PSP Domain D: Disturbing and Aggressive Behaviours at Week 6 | PSP domain D: disturbing and aggressive behaviours were categorised as "aggressive" (corresponding to mild, manifest, marked, severe, or very severe) or "nonaggressive" (corresponding to absent) | FAS. As this was based on observed cases, only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used. | Posted | Number | percentage of aggressive patients | Week 6 |
|
|
|
| 6 |
| 161 |
| 44 |
| 161 |
| EG001 | Brexpiprazole | Brexpiprazole: 2-4 mg/day, once daily, tablets, orally | 7 | 150 | 48 | 150 |
| EG002 | Quetiapine | Active Reference Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally | 2 | 153 | 73 | 153 |
| Grand mal convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
Not provided