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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent participants (ages 13-17) with a DSM-5 diagnosis of schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De Novo (Conversion Period) | Experimental | 1-3 milligrams/day (mg/day) brexpiprazole for 1 to 4 weeks |
|
| Prior and Current Brexpiprazole (Open-label Treatment Period) | Experimental | 1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day |
|
| Prior Aripiprazole and Current Brexpiprazole (Open-label Treatment Period) | Experimental | 1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day |
|
| Prior Placebo and Current Brexpiprazole (Open-label Treatment Period) | Experimental | 1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day |
|
| De Novo (Open-label Treatment Period) | Experimental | 1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Once daily, oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. | From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months). |
| Number of Participants With Serious Treatment Emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongs hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after the last dose. | From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months). |
| Number of Participants Who Discontinued the Trial Due to AEs | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. Participants who discontinued the trial due to AEs were recorded. | From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Units Per Liter) | Clinical laboratory assessments included clinical chemistry (alanine aminotransferase [ALT], alkaline phosphatase, aspartate aminotransferase [AST], creatinine phosphokinase (CPK), gamma glutamyl transferase, lactate dehydrogenase. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discontinuation Due to AEs | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Guthrie, MD | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site #101 | Dothan | Alabama | 36303 | United States | ||
| Clinical Research Site #128 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40520975 | Derived | Atkinson SD, Shah A, Burgess MV, Hefting N, Chen D, Ward C. Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia: A Long-Term, Open-Label Study. JAACAP Open. 2024 May 27;3(2):313-322. doi: 10.1016/j.jaacop.2024.04.005. eCollection 2025 Jun. |
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Of the 295 participants who were enrolled for the study, 294 participants received the study treatment, and 1 participant did not receive the study drug. All eligible participants who rolled over from the previous study 331-10-234 (NCT03198078), and de novo participants received brexpiprazole tablets during this study.
Participants took part in the study at multiple sites globally from 23 August 2017 to 22 April 2025. 14 participants underwent a cross-titration and received brexpiprazole for up to 4 weeks in conversion period followed by subsequent enrollment in De-Novo open label treatment (OLT) period.
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| ID | Title | Description |
|---|---|---|
| FG000 | De Novo (Conversion Period) | Participants underwent a cross-titration and received brexpiprazole tablets, orally, once a day (QD), for up to 4 weeks. The dose was increased up to 3 milligrams/day (mg/day) during cross-titration. |
| FG001 | Prior & Current Brexpiprazole (OLT Period) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Conversion Period (4 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2021 | Dec 16, 2025 |
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| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milligrams Per Deciliter) | Clinical laboratory assessments included clinical chemistry (bilirubin, urea nitrogen, calcium, glucose, cholesterol including low-density lipoprotein (LDL-C), creatinine, Triglycerides [TG]). | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Percentage) | Clinical laboratory assessments of HbA1c are reported in this outcome measure. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Million Cells Per Microliter) | Clinical laboratory assessments included hematology including the red blood cell count (RBC Count). | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Clinical Laboratory Tests (Parameters Assessed in Thousand Cells Per Microliter) | Clinical laboratory assessments included hematology (basophils, eosinophils, neutrophils, leukocytes, lymphocytes, white blood cell (WBC) count, platelets). | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Laboratory Tests (Parameters That Were Unitless) | Clinical laboratory assessments of pH are reported in this outcome measure. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Nanograms Per Milliliter) | Clinical laboratory assessments included prolactin for both males and females. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milliequivalents Per Liter) | Clinical laboratory assessments including chloride and potassium are reported in this outcome measure. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests | Laboratory assessments included hematology, chemistry, and urinalysis. Abnormality criteria included: In mg/dL [high bilirubin≥2.0, low calcium≤8.2, high cholesterol fasting≥240, HDL-C, Fasting<40 male(M)/ < 50 female(F); LDL-C, fasting≥160, high glucose, fasting≥100, non-fasting≥200 high TG, fasting≥150, high urate≥8.5 F/≥10.5 M, high protein urine≥2 units increase]; high creatine kinase(units per liter [U/L])>3xupper limit of normal (ULN)]; high eosinophils/leukocytes ≥10%;ALT>3×ULN; in mEq/L [Cl≤ 90; potassium≤ 2.5; sodium low≤ 126, high ≥156]; platelets≤75000/mm3; hemoglobin≤11g/dL M/≤ 9.5 F; glucose, urine≥2 units inc.; casts≥2 units inc.; hematocrit≤37% and decrease of≥3% points, M/≤ 32% and ≥3% points dec.,F. Number of participants with clinically significant laboratory test abnormalities were reported as per criteria defined in protocol. The categories with at least 1 participant with clinically significant abnormalities are reported. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Beats Per Minute) | Vital sign measurements included pulse rate assessed in beats per minute in standing and supine position. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Millimeters of Mercury) | Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure measurements were made in the supine and standing positions after the participant has been in each position at least 3 minutes. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Centimeters) | Vital sign measurements included height assessed in centimeters. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms) | Vital sign measurements included weight assessed in kilograms. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Celsius) | Vital sign measurements included temperature assessed in celsius. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Z-Score) | Vital sign measurements- Z-score for body weight (BW), height, and BMI. To adjust for normal growth, z-scores were derived, which normalize for the natural growth of pediatric patients and adolescents. Z-score was calculated as the deviation of the participant's each parameter from the mean for the respective parameter of the reference population divided by the standard deviation (SD) for the reference population. Z-score-0 represents the population mean for the respective parameter. Positive Z-scores-values above the mean, negative Z-scores indicate values below the mean. BW and BMI: Higher Z-scores-Potential overweight/obesity (worse outcome if excessive). Lower Z-scores -Underweight (worse outcome if extreme). Height: Higher Z-scores-Taller than average (neutral unless clinically relevant). Lower Z-scores → Short stature (may indicate growth issues). Z ≥ +2-Above normal range (e.g., overweight or obesity for BMI). Z ≤ -2-Below normal range (e.g., underweight or short stature). | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms Per Meter Square) | Vital sign measurements included body mass index (BMI). | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital sign measurements included SBP, and DBP, pulse rate, body temperature, body weight, BMI, and height. Vital sign measurements included pulse rate in supine and standing positions (low: <50 beats per minute [bpm] and decrease ≥15 bpm; High: >120 bpm and increase ≥15 bpm), SBP in supine and standing positions (low: <110 mmHg and decrease ≥20 mmHg; High: >120 mmHg and increase ≥20 mmHg), DBP in supine and standing positions (low: <60 mmHg and decrease ≥15 mmHg; High: >80 mmHg and increase ≥15 mmHg), weight in kg (low: ≥7% decrease; High: ≥7% increase), orthostatic hypotension, (≥20mmHg decrease in SBP or ≥10 mmHg in DBP in heart rate from supine to standing). Number of participants with clinically significant abnormalities in vital signs were reported as per criteria defined in protocol. The categories with at least one participant with clinically significant abnormalities in vital signs are reported. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in Electrocardiogram (ECG) (Parameters Assessed in Milliseconds) | 12-lead ECG recordings were obtained for parameters including PR interval, QRS duration, QT interval, QTcB [QT interval as corrected for heart rate by Bazett's formula] interval, QTcF [QT interval as corrected for heart rate by Fridericia's formula] interval, QTcN [QT interval corrected for heart rate by the FDA Neuropharm] interval, and RR interval. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in ECG Parameters (Parameters Assessed in Beats Per Minute) | Twelve-lead ECG recordings were obtained for parameters including mean heart rate. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Number of Participants With Clinically Significant Abnormalities in ECG Parameters | 12-lead ECG recordings were obtained for certain parameters and the 12-lead ECG abnormality criteria included bradycardia ≤ 50 bpm and decrease ≥15 bpm; sinus bradycardia ≤ 50 bpm and decrease of ≥ 15 bpm, supraventricular premature beat (SVPB)-not present at baseline and present post baseline, ventricular premature beat (VPB)- not present at baseline and present post baseline; and primary (1°) atrioventricular (AV) block (PR ≥200 milliseconds [msec] and increase of ≥50 msec, right bundle-branch block (RBBB) and symmetrical T-wave inversion (Sym T Wave Inv) - both not present at baseline and present post baseline; Increase in QTc-QTcF ≥ 450 msec for males, ≥ 470 msec for females. Number of participants with clinically significant ECG abnormalities was reported as per the criteria defined in the protocol. The categories with at least 1 participant with clinically significant ECG abnormalities are reported. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline on the Abnormal Involuntary Movement Scale (AIMS) Total Score | The AIMS assessment consists of 12 items rating the involuntary movements: Facial and oral movements (4 items), extremity movements (2 items), and trunk movements (1 item) were observed unobtrusively while the participant is at rest and the investigator also made global judgments on the participant's dyskinesias (2 items), and dental status (2 items). Severity of each item was rated on a 5-point scale, with a score of 0 (absence of symptoms) to 4 (severe condition). Total Score is the sum of the scores of all 12 items, ranging from 0 to 48, higher scores indicate severe condition. A negative change reflects an improvement or reduction in the severity of abnormal movements. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline on the Simpson-Angus Scale (SAS) Total Score | The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of zero representing absence of symptoms, and a score of 4 representing a severe condition. The SAS Total Score is the sum of the scores for all 10 items, ranging from 0-40. A negative change reflects an improvement or reduction in Parkinsonism severity. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Change From Baseline in the Barnes Akathisia Rating Scale (BARS) Total Score | The BARS score is based only on the item of "Global Clinical Assessment of Akathisia". The BARS consists of 4 items related to akathisia as follows. Item 1: objective observation of akathisia by the investigator; Item 2: subjective feelings of restlessness by the participant; Item 3: subjective distress due to akathisia; and Item 4: global clinical assessment of akathisia. The first 3 items will be rated on a 4-point Likert scale from 0 to 3, with 0 representing absence of symptoms and 3 representing a severe condition. The BARS global clinical assessment score refers to the ratings from the 4th item Global Clinical Assessment of Akathisia, which is a 6-point Likert scale from 0 to 5, with 0 representing absence of symptoms and 5 representing severe akathisia. Total score is the sum of the scores of all 4 items, ranging from 0 to 14. Higher score indicates severe akathisia. A negative change from baseline reflects improvement or reduction in the severity of akathisia symptoms. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a scale used to report at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any of the following items: actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior. The suicidal ideation total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) and the total score ranges from 0 to 25. Lower scores indicate improvement. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Number of Participants With Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale | The UKU rating scale is a semi-structured interview used to assess the side effects of participants being treated with antipsychotic drugs. Each item (i.e., each symptom) of the UKU side effects is defined by the means of a 4-point-scale (0-1-2-3) if it is assessed in psychic, autonomic (auto), neurologic, other categories. In general, Degree 0 means "doubtfully or not present (NP)", and Degrees 1, 2, and 3 indicate that the symptom is present to a mild, moderate or severe degree, respectively. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Number of Participants With at Least One Occurrence of Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) | The NY-AACENT is used to detect changes in cognitive function for neurological or psychiatric problems, specifically created to be used in pediatric population (ages 12 -17), but could be used with other age groups, as appropriate. Each of the 7 items is derived from the 7 domains as follows: Working Memory, Attention/Vigilance, Verbal Learning/Memory, Visual Learning/Memory, Reasoning and Problem Solving, Speed of Processing, and Social Cognition. Each score is derived as follows: 0=not present in the past week; 1=present (during past week) and mild; 2=present (during past week) and moderate; 3=present (during past week) and severe; and 4=present (during past week) and extreme; and the item score is set to missing/unknown. The NY-AACENT total score is calculated by summing up 7 individual item scores at participant-visit level. The Total range is 0-28. Higher scores reflects greater severity and frequency of cognitive problems and lower scores shows absence or mild cognitive issues. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Number of Participants With Stages of Tanner Scale Score at Baseline and Month 24 | The Tanner scale is a classification system used to assess physical development during puberty, detailing five distinct stages of growth. The Tanner Staging Scale assessment consists of 2 domains for girls and 3 domains for boys. Participants with change in Tanner Staging Scale (Stage 1-5) Score are reported. | Baseline, Month 24 |
| Change From Baseline in the 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) to 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 ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. A negative change from baseline reflects improvement or reduction in symptom severity. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Change From Baseline in the PANSS Positive Subscale Scores | 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) to 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive (+ve) scale items, 7 negative (-ve) scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. A negative change from baseline reflects improvement or reduction in symptom severity. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Change From Baseline in the PANSS Negative Subscale Scores | 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) to 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 ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. A negative (-ve) change from baseline reflects improvement or reduction in symptom severity. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score | The CGAS is a 100-point rating scale measuring psychological, social and school functioning for children aged 6-17. The scale is separated into 10-point sections with the score ranging from 0-100, 1 to 10 indicates the need for constant supervision and 91 to 100 indicates superior functioning in all areas. A positive change from baseline reflects improvement in functioning. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Clinical Global Impression Severity (CGI-S) Scale Score | The CGI-S scale is an investigator-rated evaluation that assesses the severity of a participant's illness on a 7-point scale, ranging from 1 to 7. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices include: 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 patients. Higher scores indicate worse condition. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Mean Clinical Global Impression - Improvement (CGI-I) Scale Score | The efficacy of brexpiprazole in the treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was entirely due to drug treatment on a 7-point scale, ranging from 0 to 7. Response choices were: 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. Higher scores indicate worse condition. | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| Anaheim |
| California |
| 92805 |
| United States |
| Clinical Research Site #105 | Culver City | California | 90230 | United States |
| Clinical Research Site #103 | Long Beach | California | 90807 | United States |
| Clinical Research Site #136 | Atlanta | Georgia | 30331 | United States |
| Clinical Research Site #148 | Kansas City | Kansas | 66160 | United States |
| Clinical Research Site #138 | Lake Charles | Louisiana | 70629 | United States |
| Clinical Research Site #124 | Las Vegas | Nevada | 89109 | United States |
| Clinical Research Site #130 | New York | New York | 10036 | United States |
| Clinical Research Site #100 | Rochester | New York | 14618 | United States |
| Clinical Research Site #121 | Kinston | North Carolina | 28501 | United States |
| Clinical Research Site #133 | Cincinnati | Ohio | 45219 | United States |
| Clinical Research Site #113 | Garfield Heights | Ohio | 44125 | United States |
| Clinical Research Site #102 | Oklahoma City | Oklahoma | 73116 | United States |
| Clinical Research Site #135 | Tulsa | Oklahoma | 74136 | United States |
| Clinical Research Site #140 | Frisco | Texas | 75034 | United States |
| Clinical Research Site #108 | Everett | Washington | 98201 | United States |
| Clinical Research Site #321 | Nice | 06200 | France |
| Clinical Research Site #283 | Naples | 80131 | Italy |
| Clinical Research Site #163 | León | Guanajuato | 37000 | Mexico |
| Clinical Research Site #165 | Guadalajara | Jalisco | 44100 | Mexico |
| Clinical Research Site #171 | Monterrey | Nuevo León | 64310 | Mexico |
| Clinical Research Site #160 | Monterrey | Nuevo León | 64710 | Mexico |
| Clinical Research Site #170 | San Luis Potosà City | San Luis Potosà | 78213 | Mexico |
| Clinical Research Site #161 | Culiacán | Sinaloa | 80230 | Mexico |
| Clinical Research Site #166 | Mérida | Yucatán | 97070 | Mexico |
| Clinical Research Site #168 | Durango | 34000 | Mexico |
| Clinical Research Site #263 | Tyniec Mały | Dolnyslask | 55-040 | Poland |
| Clinical Research Site #266 | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Clinical Research Site #269 | Gdansk | Polorskie | 80-542 | Poland |
| Clinical Research Site #260 | Poznan | 60-744 | Poland |
| Clinical Research Site #272 | Poznan | 61-485 | Poland |
| Clinical Research Site #270 | Wałbrzych | 58-309 | Poland |
| Clinical Research Site #267 | Wroclaw | 54-617 | Poland |
| Clinical Research Site #244 | Bucharest | 041914 | Romania |
| Clinical Research Site #241 | Cluj-Napoca | 400660 | Romania |
| Clinical Research Site #243 | Iași | IS700282 | Romania |
| Clinical Research Site #242 | Timișoara | 300329 | Romania |
| Clinical Research Site #542 | Arkhangelsk | Primorsky District | 163530 | Russia |
| Clinical Research Site #543 | Stavropol | Stavropolskiy Kray | 355038 | Russia |
| Clinical Research Site #545 | Moscow | 127083 | Russia |
| Clinical Research Site #541 | Saint Petersburg | 192019 | Russia |
| Clinical Research Site #540 | Saint Petersburg | 197341 | Russia |
| Clinical Research Site #544 | Yaroslavl | 150003 | Russia |
| Clinical Research Site #500 | Belgrade | 11000 | Serbia |
| Clinical Research Site #504 | Belgrade | 11000 | Serbia |
| Clinical Research Site #503 | Kragujevac | 34000 | Serbia |
| Clinical Research Site #502 | Niš | 18000 | Serbia |
| Clinical Research Site #501 | Novi Sad | 21000 | Serbia |
| Clinical Research Site #224 | Torremolinos | Malaga | 29620 | Spain |
| Clinical Research Site #526 | Poltava | Poltava Oblast | 36013 | Ukraine |
| Clinical Research Site #527 | Dnipro | 49027 | Ukraine |
| Clinical Research Site #523 | Kharkiv | 61068 | Ukraine |
| Clinical Research Site #521 | Kharkiv | 61153 | Ukraine |
| Clinical Research Site #522 | Kherson | 73488 | Ukraine |
| Clinical Research Site #520 | Lviv | 79021 | Ukraine |
| Clinical Research Site #525 | Ternopil | 46027 | Ukraine |
Participants who received brexpiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, once a day (QD) at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. Open-label Treatment Period = OLT Period. |
| FG002 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| FG003 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| FG004 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| COMPLETED |
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| NOT COMPLETED |
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| Open-label Period (About 25 Months) |
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The enrolled sample consists of all consented/assented participants who were screened for eligibility and deemed eligible.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prior and Current Brexpiprazole | Participants who received brexpiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, once a day (QD) at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. Open-label Treatment Period = OLT Period. |
| BG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| BG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| BG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. | The safety population included all enrolled participants who received at least one dose of the study drug. Participants with conversion were analyzed separately in addition to their analysis in treatment period arms. | Posted | Count of Participants | Participants | From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months). |
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| Primary | Number of Participants With Serious Treatment Emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongs hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after the last dose. | The safety population included all enrolled participants who received at least one dose of the study drug. Participants with conversion were analyzed separately in addition to their analysis in treatment period arms. | Posted | Count of Participants | Participants | From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months). |
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| Primary | Number of Participants Who Discontinued the Trial Due to AEs | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. Participants who discontinued the trial due to AEs were recorded. | The safety population included all enrolled participants who received at least one dose of the study drug. Participants with conversion were analyzed separately in addition to their analysis in treatment period arms. | Posted | Count of Participants | Participants | From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months). |
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| Secondary | Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Units Per Liter) | Clinical laboratory assessments included clinical chemistry (alanine aminotransferase [ALT], alkaline phosphatase, aspartate aminotransferase [AST], creatinine phosphokinase (CPK), gamma glutamyl transferase, lactate dehydrogenase. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | units per liter (U/L) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milligrams Per Deciliter) | Clinical laboratory assessments included clinical chemistry (bilirubin, urea nitrogen, calcium, glucose, cholesterol including low-density lipoprotein (LDL-C), creatinine, Triglycerides [TG]). | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Percentage) | Clinical laboratory assessments of HbA1c are reported in this outcome measure. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | percentage (%) of HbA1c | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Million Cells Per Microliter) | Clinical laboratory assessments included hematology including the red blood cell count (RBC Count). | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | million cells/microliter | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Clinical Laboratory Tests (Parameters Assessed in Thousand Cells Per Microliter) | Clinical laboratory assessments included hematology (basophils, eosinophils, neutrophils, leukocytes, lymphocytes, white blood cell (WBC) count, platelets). | The safety population included all enrolled participants who received at least one dose of the study drug. Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | thousand cells per microliter | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Laboratory Tests (Parameters That Were Unitless) | Clinical laboratory assessments of pH are reported in this outcome measure. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | unitless | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Nanograms Per Milliliter) | Clinical laboratory assessments included prolactin for both males and females. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milliequivalents Per Liter) | Clinical laboratory assessments including chloride and potassium are reported in this outcome measure. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | milliequivalents per liter (mEq/dL) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests | Laboratory assessments included hematology, chemistry, and urinalysis. Abnormality criteria included: In mg/dL [high bilirubin≥2.0, low calcium≤8.2, high cholesterol fasting≥240, HDL-C, Fasting<40 male(M)/ < 50 female(F); LDL-C, fasting≥160, high glucose, fasting≥100, non-fasting≥200 high TG, fasting≥150, high urate≥8.5 F/≥10.5 M, high protein urine≥2 units increase]; high creatine kinase(units per liter [U/L])>3xupper limit of normal (ULN)]; high eosinophils/leukocytes ≥10%;ALT>3×ULN; in mEq/L [Cl≤ 90; potassium≤ 2.5; sodium low≤ 126, high ≥156]; platelets≤75000/mm3; hemoglobin≤11g/dL M/≤ 9.5 F; glucose, urine≥2 units inc.; casts≥2 units inc.; hematocrit≤37% and decrease of≥3% points, M/≤ 32% and ≥3% points dec.,F. Number of participants with clinically significant laboratory test abnormalities were reported as per criteria defined in protocol. The categories with at least 1 participant with clinically significant abnormalities are reported. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Count of Participants | Participants | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Vital Signs (Parameters Assessed in Beats Per Minute) | Vital sign measurements included pulse rate assessed in beats per minute in standing and supine position. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | beats per minute (beats/min) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Vital Signs (Parameters Assessed in Millimeters of Mercury) | Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure measurements were made in the supine and standing positions after the participant has been in each position at least 3 minutes. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Vital Signs (Parameters Assessed in Centimeters) | Vital sign measurements included height assessed in centimeters. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | centimeters (cm) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms) | Vital sign measurements included weight assessed in kilograms. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | kilograms (kg) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Vital Signs (Parameters Assessed in Celsius) | Vital sign measurements included temperature assessed in celsius. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | celsius (°C) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Vital Signs (Parameters Assessed in Z-Score) | Vital sign measurements- Z-score for body weight (BW), height, and BMI. To adjust for normal growth, z-scores were derived, which normalize for the natural growth of pediatric patients and adolescents. Z-score was calculated as the deviation of the participant's each parameter from the mean for the respective parameter of the reference population divided by the standard deviation (SD) for the reference population. Z-score-0 represents the population mean for the respective parameter. Positive Z-scores-values above the mean, negative Z-scores indicate values below the mean. BW and BMI: Higher Z-scores-Potential overweight/obesity (worse outcome if excessive). Lower Z-scores -Underweight (worse outcome if extreme). Height: Higher Z-scores-Taller than average (neutral unless clinically relevant). Lower Z-scores → Short stature (may indicate growth issues). Z ≥ +2-Above normal range (e.g., overweight or obesity for BMI). Z ≤ -2-Below normal range (e.g., underweight or short stature). | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | z-score | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms Per Meter Square) | Vital sign measurements included body mass index (BMI). | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | kilograms per meter square (kg/m^2) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital sign measurements included SBP, and DBP, pulse rate, body temperature, body weight, BMI, and height. Vital sign measurements included pulse rate in supine and standing positions (low: <50 beats per minute [bpm] and decrease ≥15 bpm; High: >120 bpm and increase ≥15 bpm), SBP in supine and standing positions (low: <110 mmHg and decrease ≥20 mmHg; High: >120 mmHg and increase ≥20 mmHg), DBP in supine and standing positions (low: <60 mmHg and decrease ≥15 mmHg; High: >80 mmHg and increase ≥15 mmHg), weight in kg (low: ≥7% decrease; High: ≥7% increase), orthostatic hypotension, (≥20mmHg decrease in SBP or ≥10 mmHg in DBP in heart rate from supine to standing). Number of participants with clinically significant abnormalities in vital signs were reported as per criteria defined in protocol. The categories with at least one participant with clinically significant abnormalities in vital signs are reported. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Count of Participants | Participants | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) (Parameters Assessed in Milliseconds) | 12-lead ECG recordings were obtained for parameters including PR interval, QRS duration, QT interval, QTcB [QT interval as corrected for heart rate by Bazett's formula] interval, QTcF [QT interval as corrected for heart rate by Fridericia's formula] interval, QTcN [QT interval corrected for heart rate by the FDA Neuropharm] interval, and RR interval. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | milliseconds (ms) | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in ECG Parameters (Parameters Assessed in Beats Per Minute) | Twelve-lead ECG recordings were obtained for parameters including mean heart rate. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | beats/min | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in ECG Parameters | 12-lead ECG recordings were obtained for certain parameters and the 12-lead ECG abnormality criteria included bradycardia ≤ 50 bpm and decrease ≥15 bpm; sinus bradycardia ≤ 50 bpm and decrease of ≥ 15 bpm, supraventricular premature beat (SVPB)-not present at baseline and present post baseline, ventricular premature beat (VPB)- not present at baseline and present post baseline; and primary (1°) atrioventricular (AV) block (PR ≥200 milliseconds [msec] and increase of ≥50 msec, right bundle-branch block (RBBB) and symmetrical T-wave inversion (Sym T Wave Inv) - both not present at baseline and present post baseline; Increase in QTc-QTcF ≥ 450 msec for males, ≥ 470 msec for females. Number of participants with clinically significant ECG abnormalities was reported as per the criteria defined in the protocol. The categories with at least 1 participant with clinically significant ECG abnormalities are reported. | The safety population included all enrolled participants who received at least one dose of the study drug. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Count of Participants | Participants | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline on the Abnormal Involuntary Movement Scale (AIMS) Total Score | The AIMS assessment consists of 12 items rating the involuntary movements: Facial and oral movements (4 items), extremity movements (2 items), and trunk movements (1 item) were observed unobtrusively while the participant is at rest and the investigator also made global judgments on the participant's dyskinesias (2 items), and dental status (2 items). Severity of each item was rated on a 5-point scale, with a score of 0 (absence of symptoms) to 4 (severe condition). Total Score is the sum of the scores of all 12 items, ranging from 0 to 48, higher scores indicate severe condition. A negative change reflects an improvement or reduction in the severity of abnormal movements. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline on the Simpson-Angus Scale (SAS) Total Score | The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of zero representing absence of symptoms, and a score of 4 representing a severe condition. The SAS Total Score is the sum of the scores for all 10 items, ranging from 0-40. A negative change reflects an improvement or reduction in Parkinsonism severity. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Change From Baseline in the Barnes Akathisia Rating Scale (BARS) Total Score | The BARS score is based only on the item of "Global Clinical Assessment of Akathisia". The BARS consists of 4 items related to akathisia as follows. Item 1: objective observation of akathisia by the investigator; Item 2: subjective feelings of restlessness by the participant; Item 3: subjective distress due to akathisia; and Item 4: global clinical assessment of akathisia. The first 3 items will be rated on a 4-point Likert scale from 0 to 3, with 0 representing absence of symptoms and 3 representing a severe condition. The BARS global clinical assessment score refers to the ratings from the 4th item Global Clinical Assessment of Akathisia, which is a 6-point Likert scale from 0 to 5, with 0 representing absence of symptoms and 5 representing severe akathisia. Total score is the sum of the scores of all 4 items, ranging from 0 to 14. Higher score indicates severe akathisia. A negative change from baseline reflects improvement or reduction in the severity of akathisia symptoms. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a scale used to report at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any of the following items: actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior. The suicidal ideation total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) and the total score ranges from 0 to 25. Lower scores indicate improvement. | The safety population included all enrolled participants who received at least one dose of the study drug. Participants with conversion were analyzed separately in addition to their analysis in treatment period arms. | Posted | Count of Participants | Participants | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Number of Participants With Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale | The UKU rating scale is a semi-structured interview used to assess the side effects of participants being treated with antipsychotic drugs. Each item (i.e., each symptom) of the UKU side effects is defined by the means of a 4-point-scale (0-1-2-3) if it is assessed in psychic, autonomic (auto), neurologic, other categories. In general, Degree 0 means "doubtfully or not present (NP)", and Degrees 1, 2, and 3 indicate that the symptom is present to a mild, moderate or severe degree, respectively. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Count of Participants | Participants | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Number of Participants With at Least One Occurrence of Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) | The NY-AACENT is used to detect changes in cognitive function for neurological or psychiatric problems, specifically created to be used in pediatric population (ages 12 -17), but could be used with other age groups, as appropriate. Each of the 7 items is derived from the 7 domains as follows: Working Memory, Attention/Vigilance, Verbal Learning/Memory, Visual Learning/Memory, Reasoning and Problem Solving, Speed of Processing, and Social Cognition. Each score is derived as follows: 0=not present in the past week; 1=present (during past week) and mild; 2=present (during past week) and moderate; 3=present (during past week) and severe; and 4=present (during past week) and extreme; and the item score is set to missing/unknown. The NY-AACENT total score is calculated by summing up 7 individual item scores at participant-visit level. The Total range is 0-28. Higher scores reflects greater severity and frequency of cognitive problems and lower scores shows absence or mild cognitive issues. | The safety population included all enrolled participants who received at least one dose of the study drug. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Count of Participants | Participants | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Number of Participants With Stages of Tanner Scale Score at Baseline and Month 24 | The Tanner scale is a classification system used to assess physical development during puberty, detailing five distinct stages of growth. The Tanner Staging Scale assessment consists of 2 domains for girls and 3 domains for boys. Participants with change in Tanner Staging Scale (Stage 1-5) Score are reported. | The safety population included all enrolled participants who received at least one dose of the study drug. Number analyzed are the participants with data available at specified timepoints. | Posted | Count of Participants | Participants | Baseline, Month 24 |
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| Other Pre-specified | Time to Discontinuation Due to AEs | Not Posted | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 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) to 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 ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. A negative change from baseline reflects improvement or reduction in symptom severity. | Efficacy Sample consists of all participants in the Safety Sample who had a baseline assessment and at least one post-baseline assessment of the PANSS Total Score. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Change From Baseline in the PANSS Positive Subscale Scores | 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) to 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive (+ve) scale items, 7 negative (-ve) scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. A negative change from baseline reflects improvement or reduction in symptom severity. | Efficacy Sample consists of all participants in the Safety Sample who had a baseline assessment and at least one post-baseline assessment of the PANSS Total Score. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the PANSS Negative Subscale Scores | 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) to 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 ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. A negative (-ve) change from baseline reflects improvement or reduction in symptom severity. | Efficacy Sample consists of all participants in the Safety Sample who had a baseline assessment and at least one post-baseline assessment of the PANSS Total Score. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score | The CGAS is a 100-point rating scale measuring psychological, social and school functioning for children aged 6-17. The scale is separated into 10-point sections with the score ranging from 0-100, 1 to 10 indicates the need for constant supervision and 91 to 100 indicates superior functioning in all areas. A positive change from baseline reflects improvement in functioning. | Efficacy Sample consists of all participants in the Safety Sample who had a baseline assessment and at least one post-baseline assessment of the PANSS Total Score. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Clinical Global Impression Severity (CGI-S) Scale Score | The CGI-S scale is an investigator-rated evaluation that assesses the severity of a participant's illness on a 7-point scale, ranging from 1 to 7. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices include: 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 patients. Higher scores indicate worse condition. | Efficacy Sample consists of all participants in the Safety Sample who had a baseline assessment and at least one post-baseline assessment of the PANSS Total Score. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
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| Secondary | Mean Clinical Global Impression - Improvement (CGI-I) Scale Score | The efficacy of brexpiprazole in the treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was entirely due to drug treatment on a 7-point scale, ranging from 0 to 7. Response choices were: 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. Higher scores indicate worse condition. | Efficacy Sample consists of all participants in the Safety Sample who had a baseline assessment and at least one post-baseline assessment of the PANSS Total Score. The data for this outcome measure was planned to be collected for only OLT period arm groups. | Posted | Mean | Standard Deviation | score on a scale | From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24) |
|
From the first dose of study drug (including the open-label treatment period and the conversion period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months)
The safety population included all enrolled participants who received at least one dose of the study drug. Participants with conversion were analyzed separately in addition to their analysis in treatment period arms.
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 | Prior and Current Brexpiprazole | Participants who received brexpiprazole in the previous study 331-10-234 were administered brexpiprazole tablets, orally, once a day (QD) at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/ day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. Open-label Treatment Period = OLT Period. | 0 | 98 | 4 | 98 | 45 | 98 |
| EG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/ day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. | 0 | 89 | 1 | 89 | 37 | 89 |
| EG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/ day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. | 0 | 87 | 3 | 87 | 42 | 87 |
| EG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/ day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. | 0 | 20 | 1 | 20 | 13 | 20 |
| EG004 | De Novo (Conversion Period) | Participants underwent a cross-titration to oral brexpiprazole 1, 2, or 3 mg/day for 1 to 4 weeks to achieve the required washout of prohibited medications during the conversion period. | 0 | 14 | 0 | 14 | 5 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Sensation in Eye | Eye disorders | MedDRA27.1 | Systematic Assessment |
| |
| Pilonidal Disease | Infections and infestations | MedDRA27.1 | Systematic Assessment |
| |
| Psychomotor Hyperactivity | Nervous system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythropenia | Blood and lymphatic system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Hyperprolactinaemia | Endocrine disorders | MedDRA27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA27.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA27.1 | Systematic Assessment |
| |
| Coronavirus Pneumonia | Infections and infestations | MedDRA27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA27.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA27.1 | Systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA27.1 | Systematic Assessment |
| |
| Coronavirus Test Positive | Investigations | MedDRA27.1 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA27.1 | Systematic Assessment |
| |
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA27.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Tension Headache | Nervous system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Intentional Self-Injury | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Emotional Disorders | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Initial Insomnia | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA27.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA27.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Otsuka Pharmaceutical Development & Commercialization, Inc. | 08446878522 | clinicaltransparency@otsuka-us.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2025 | Dec 16, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Non-Compliance With Study Drug |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Participant |
|
| Withdrawal by Caregiver |
|
| Physician Decision |
|
| Reason Not Specified |
|
| Male |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiin or Other Pacific Islander |
|
| Other |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Other |
|
| Unknown |
|
| Missing |
|
| OG002 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG004 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
|
|
| OG002 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG004 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
|
|
| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
|
|
| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
|
|
Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
|
|
Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 |
| Prior Aripiprazole & Current Brexpiprazole (OLT Period) |
Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| Prior Aripiprazole & Current Brexpiprazole (OLT Period) |
Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| Prior Aripiprazole & Current Brexpiprazole (OLT Period) |
Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG002 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG004 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days.
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Participants who received aripiprazole in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG002 | Prior Placebo & Current Brexpiprazole (OLT Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study 331-10-234, were administered brexpiprazole tablets, orally, QD at a starting dose of 0.5 mg/day from Day 1 to Day 4 in this study. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
| OG003 | De Novo (OLT Period) | De novo participants who rolled over from the previous study 331-10-234, and newly enrolled participants in this study were administered brexpiprazole tablets, orally, QD, at a starting dose of 0.5 mg/day from Day 1 to Day 4. Thereafter, the dose was titrated to 1 mg/day by Day 7, with the option of a 1 mg increase or decrease if needed and tolerated. The dose was adjusted within the range of 1 mg/day to 2 mg/day by Day 14, 1 mg/day to 3 mg/day by Day 21, and up to a maximum of 4 mg/day by Day 22 based on clinical judgement. Participants continued to receive flexible dose of brexpiprazole (1 mg/day to 4 mg/day) up to Month 24. Participants were followed for safety for another 21 days. |
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| OG001 | Prior Aripiprazole (Open-label Treatment Period) | Participants who received aripiprazole in the previous study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22 in the current study |
| OG002 | Prior Placebo (Open-label Treatment Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22 in the current study |
| OG003 | De Novo (Open-label Treatment Period) | De novo participants who rolled over from the previous study, and newly enrolled participants in this study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22. De novo participants, for whom a washout period was not appropriate in the opinion of the investigator entered a conversion period to cross-titrate from their current antipsychotic treatments to monotherapy with brexpiprazole 1, 2, or 3 mg/day and washout from prohibited medications. Participants who completed the conversion period entered the de novo open-label treatment period. |
|
|
| OG001 | Prior Aripiprazole (Open-label Treatment Period) | Participants who received aripiprazole in the previous study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22 in the current study |
| OG002 | Prior Placebo (Open-label Treatment Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22 in the current study |
| OG003 | De Novo (Open-label Treatment Period) | De novo participants who rolled over from the previous study, and newly enrolled participants in this study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22. De novo participants, for whom a washout period was not appropriate in the opinion of the investigator entered a conversion period to cross-titrate from their current antipsychotic treatments to monotherapy with brexpiprazole 1, 2, or 3 mg/day and washout from prohibited medications. Participants who completed the conversion period entered the de novo open-label treatment period. |
|
|
| OG001 | Prior Aripiprazole (Open-label Treatment Period) | Participants who received aripiprazole in the previous study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22 in the current study |
| OG002 | Prior Placebo (Open-label Treatment Period) | Participants who received brexpiprazole or aripiprazole matching placebo tablets in the previous study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22 in the current study |
| OG003 | De Novo (Open-label Treatment Period) | De novo participants who rolled over from the previous study, and newly enrolled participants in this study were administered brexpiprazole tablets, starting with a dose of 0.5 mg/day by Day 4, titrated up to 1 mg/day by Day 7, with a 1 mg increase or decrease if needed and tolerated, 1 or 2 mg/day by Days 14, 1-3 mg/ day by Days 21, up to a maximum dose of 4 mg by Day 22. De novo participants, for whom a washout period was not appropriate in the opinion of the investigator entered a conversion period to cross-titrate from their current antipsychotic treatments to monotherapy with brexpiprazole 1, 2, or 3 mg/day and washout from prohibited medications. Participants who completed the conversion period entered the de novo open-label treatment period. |
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