A Phase 3 interventional study of Brexpiprazole in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 57 sites in 10 countries. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 3, Interventional, and Supportive care
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.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 295 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1-3 milligrams/day (mg/day) brexpiprazole for 1 to 4 weeks
Drug: Brexpiprazole
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Drug: Brexpiprazole
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Drug: Brexpiprazole
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Drug: Brexpiprazole
1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Drug: Brexpiprazole
Once daily, oral tablets
Also known as: OPC-34712
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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.
Time frame: 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 Milligrams Per Deciliter)
Clinical laboratory assessments included clinical chemistry (bilirubin, urea nitrogen, calcium, glucose, cholesterol including low-density lipoprotein (LDL-C), creatinine, Triglycerides \[TG\]).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)
Time to Discontinuation Due to AEs
Time frame: From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)
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.
| Milestone | De Novo (Conversion Period) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|---|
| Started | 14 | 0 | 0 | 0 | 0 |
| Completed | 14 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | De Novo (Conversion Period) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|---|
| Started | 0 | 99 | 89 | 87 | 20 |
| Completed | 0 | 58 | 59 | 50 | 11 |
| Not completed | 0 | 41 | 30 | 37 | 9 |
| Withdrew: Adverse event | 0 | 4 | 2 | 3 | 0 |
| Withdrew: Lack of efficacy | 0 | 4 | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 5 | 6 | 3 | 3 |
| Withdrew: Non-compliance with study drug | 0 | 1 | 1 | 1 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 3 | 0 |
| Withdrew: Withdrawal by participant | 0 | 14 | 8 | 11 | 4 |
| Withdrew: Withdrawal by caregiver | 0 | 10 | 5 | 11 | 1 |
| Withdrew: Physician decision | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Reason not specified | 0 | 2 | 3 | 4 | 1 |
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 | De Novo (Conversion Period) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | 5 | 58 | 54 | 63 | 13 |
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.
| Participants | De Novo (Conversion Period) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|---|
| Number of Participants With Serious Treatment Emergent Adverse Events (TEAEs) | 0 | 4 | 1 | 3 | 1 |
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.
| Participants | De Novo (Conversion Period) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|---|
| Number of Participants Who Discontinued the Trial Due to AEs | 0 | 4 | 2 | 3 | 0 |
Clinical laboratory assessments included clinical chemistry (alanine aminotransferase \[ALT\], alkaline phosphatase, aspartate aminotransferase \[AST\], creatinine phosphokinase (CPK), gamma glutamyl transferase, lactate dehydrogenase.
| units per liter (U/L) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| ALT | 0.02 ± 15.35 | 2.09 ± 10.91 | 0.60 ± 10.83 | -2.30 ± 15.13 |
| AST | -0.43 ± 7.20 | 0.12 ± 8.62 | -0.92 ± 6.69 | -1.10 ± 8.35 |
| Alkaline Phosphatase | -25.14 ± 59.48 | -22.36 ± 60.45 | -13.94 ± 50.63 | -28.45 ± 58.93 |
| CPK, Total | -7.12 ± 114.70 | -17.98 ± 182.22 | -10.62 ± 126.12 | -69.70 ± 283.72 |
| Lactate Dehydrogenase | -1.02 ± 31.03 | 0.43 ± 29.70 | -1.75 ± 26.13 | -6.05 ± 24.05 |
| Gamma Glutamyl Transferase | 0.41 ± 5.97 | 1.21 ± 12.73 | 2.22 ± 13.01 | -0.35 ± 12.91 |
Clinical laboratory assessments included clinical chemistry (bilirubin, urea nitrogen, calcium, glucose, cholesterol including low-density lipoprotein (LDL-C), creatinine, Triglycerides \[TG\]).
| milligrams per deciliter (mg/dL) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Bilirubin | 0.04 ± 0.27 | 0.02 ± 0.25 | -0.05 ± 0.25 | -0.02 ± 0.48 |
| Calcium | -0.07 ± 0.46 | -0.16 ± 0.45 | -0.10 ± 0.34 | 0.00 ± 0.39 |
| Glucose, Fasting | -0.12 ± 13.67 | 0.32 ± 11.32 | 3.11 ± 16.61 | -2.05 ± 15.11 |
| LDL-C, Fasting | 0.46 ± 27.13 | 7.51 ± 25.31 | 6.20 ± 21.44 | 10.11 ± 30.02 |
| Cholesterol, Fasting | 2.68 ± 32.91 | 8.69 ± 29.84 | 8.88 ± 28.02 | 16.89 ± 35.93 |
| TG, Fasting | 11.46 ± 51.00 | 1.32 ± 57.12 | 2.84 ± 56.16 | 5.21 ± 42.45 |
| Creatinine | 0.04 ± 0.14 | 0.02 ± 0.14 | 0.03 ± 0.12 | 0.00 ± 0.12 |
| Urea Nitrogen | 0.50 ± 3.57 | 0.72 ± 3.99 | 0.25 ± 4.85 | 0.60 ± 4.10 |
| Glucose, Urine | -0.01 ± 0.10 | 0.00 ± 0.00 | 0.00 ± 0.08 | 0.00 ± 0.00 |
| Protein, Urine | 0.02 ± 0.49 | -0.13 ± 0.45 | -0.02 ± 0.37 | -0.05 ± 0.32 |
Clinical laboratory assessments of HbA1c are reported in this outcome measure.
| percentage (%) of HbA1c | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Percentage) | 0.01 ± 0.30 | -0.01 ± 0.32 | 0.05 ± 0.45 | -0.05 ± 0.26 |
Clinical laboratory assessments included hematology including the red blood cell count (RBC Count).
| million cells/microliter | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Million Cells Per Microliter) | 0.09 ± 0.36 | 0.06 ± 0.29 | 0.06 ± 0.33 | 0.01 ± 0.31 |
Clinical laboratory assessments included hematology (basophils, eosinophils, neutrophils, leukocytes, lymphocytes, white blood cell (WBC) count, platelets).
| thousand cells per microliter | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Basophils | 0.00 ± 0.05 | -0.01 ± 0.05 | -0.01 ± 0.05 | 0.01 ± 0.02 |
| Eosinophils | 0.02 ± 0.13 | 0.02 ± 0.11 | -0.01 ± 0.12 | 0.04 ± 0.14 |
| Lymphocytes | 0.07 ± 0.58 | -0.11 ± 0.62 | -0.13 ± 0.58 | 0.02 ± 0.63 |
| Neutrophils | -0.18 ± 1.39 | 0.00 ± 1.48 | -0.05 ± 1.79 | -0.44 ± 1.32 |
| WBC | -0.08 ± 1.53 | -0.09 ± 1.87 | -0.22 ± 1.99 | -0.35 ± 1.35 |
| Platelets | -2.67 ± 59.28 | -11.01 ± 43.48 | -5.05 ± 56.07 | 19.20 ± 55.50 |
Clinical laboratory assessments of pH are reported in this outcome measure.
| unitless | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in Laboratory Tests (Parameters That Were Unitless) | 0.04 ± 0.63 | -0.06 ± 0.51 | 0.03 ± 0.60 | 0.05 ± 0.69 |
Clinical laboratory assessments included prolactin for both males and females.
| nanograms per milliliter (ng/ml) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Prolactin - Females | -8.34 ± 15.27 | 9.86 ± 10.24 | 6.07 ± 21.14 | -1.73 ± 9.41 |
| Prolactin - Males | 0.83 ± 12.56 | 7.70 ± 8.82 | 2.42 ± 12.86 | -0.79 ± 23.91 |
Clinical laboratory assessments including chloride and potassium are reported in this outcome measure.
| milliequivalents per liter (mEq/dL) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Chloride | 0.16 ± 2.56 | -0.35 ± 2.77 | 0.19 ± 3.18 | 0.45 ± 3.59 |
| Potassium | 0.02 ± 0.36 | -0.09 ± 0.46 | 0.02 ± 0.45 | 0.04 ± 0.37 |
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.
| Participants | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| ALT: High | 1 | 1 | 0 | 1 |
| Bilirubin: High | 2 | 0 | 0 | 0 |
| Calcium: Low | 1 | 3 | 0 | 0 |
| Chloride: Low | 1 | 0 | 1 | 0 |
| Cholesterol, Fasting: High | 2 | 1 | 5 | 3 |
| Creatine Kinase: High | 8 | 9 | 4 | 0 |
| Glucose, Fasting: High | 29 | 26 | 18 | 9 |
| HDL Cholesterol, Fasting: Low | 25 | 21 | 17 | 2 |
| LDL-C, Fasting: High | 3 | 0 | 3 | 2 |
| Potassium: Low | 1 | 0 | 0 | 0 |
| Sodium: Low | 0 | 0 | 1 | 0 |
| Sodium: High | 1 | 0 | 0 | 0 |
| TG,Fasting: High | 21 | 23 | 20 | 5 |
| Urate: High | 1 | 0 | 0 | 0 |
| Eosinophils/Leukocytes: High | 0 | 2 | 1 | 0 |
| Hematocrit: Low | 2 | 3 | 2 | 0 |
| Hemoglobin: Low | 1 | 4 | 3 | 0 |
| Platelets: Low | 1 | 0 | 0 | 0 |
| Glucose, Urine: High | 2 | 0 | 1 | 0 |
| Protein, Urine: High | 1 | 0 | 1 | 0 |
| Prolactin: High | 23 | 29 | 27 | 8 |
Vital sign measurements included pulse rate assessed in beats per minute in standing and supine position.
| beats per minute (beats/min) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Pulse Rate: Standing | -0.6 ± 12.8 | -1.9 ± 10.0 | -0.5 ± 10.6 | -2.8 ± 11.0 |
| Pulse Rate: Supine | 1.1 ± 10.2 | -1.6 ± 10.1 | -0.5 ± 14.5 | 0.7 ± 11.7 |
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.
| millimeters of mercury (mmHg) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| SBP: Standing | 0.7 ± 9.0 | 0.5 ± 9.6 | 1.5 ± 10.8 | -1.7 ± 6.5 |
| SBP: Supine | 0.7 ± 8.9 | 0.4 ± 9.5 | 2.1 ± 11.5 | -0.3 ± 6.8 |
| DBP: Standing | 0.2 ± 7.7 | 1.2 ± 8.5 | 0.2 ± 8.3 | 0.1 ± 6.7 |
| DBP: Supine | 0.8 ± 8.5 | 0.4 ± 7.4 | -0.5 ± 7.5 | 0.4 ± 8.9 |
Vital sign measurements included height assessed in centimeters.
| centimeters (cm) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Centimeters) | 1.4 ± 5.4 | 2.4 ± 4.5 | 2.0 ± 4.2 | 3.5 ± 4.2 |
Vital sign measurements included weight assessed in kilograms.
| kilograms (kg) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms) | 3.8 ± 5.8 | 4.2 ± 7.5 | 3.8 ± 6.6 | 3.4 ± 4.3 |
Vital sign measurements included temperature assessed in celsius.
| celsius (°C) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Celsius) | -0.0 ± 0.4 | -0.0 ± 0.3 | -0.0 ± 0.4 | 0.0 ± 0.3 |
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).
| z-score | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Z-Score of Body Weight | -0.0 ± 0.5 | -0.0 ± 0.5 | 0.0 ± 0.5 | 0.0 ± 0.4 |
| Z-Score of Height | -0.1 ± 0.8 | 0.1 ± 0.5 | 0.0 ± 0.5 | 0.3 ± 0.6 |
| Z-Score of BMI | 0.0 ± 0.6 | -0.1 ± 0.6 | 0.0 ± 0.6 | -0.1 ± 0.5 |
Vital sign measurements included body mass index (BMI).
| kilograms per meter square (kg/m^2) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms Per Meter Square) | 1.0 ± 2.3 | 0.9 ± 2.8 | 0.8 ± 2.2 | 0.1 ± 2.2 |
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.
| Participants | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| SBP, Standing: Low | 7 | 5 | 6 | 0 |
| SBP, Standing: High | 10 | 11 | 14 | 2 |
| SBP, Supine: Low | 9 | 7 | 5 | 0 |
| SBP, Supine: High | 3 | 8 | 9 | 0 |
| DBP, Standing: Low | 1 | 5 | 1 | 1 |
| DBP, Standing: High | 14 | 14 | 18 | 3 |
| DBP, Supine: Low | 6 | 3 | 3 | 2 |
| DBP, Supine: High | 12 | 11 | 8 | 0 |
| Pulse Rate, Standing: High | 0 | 0 | 1 | 0 |
| Pulse Rate, Supine: Low | 0 | 0 | 1 | 0 |
| Pulse Rate, Supine: High | 0 | 0 | 1 | 0 |
| Weight: Low | 9 | 5 | 9 | 1 |
| Weight: High | 46 | 40 | 40 | 13 |
| Orthostatic Hypotension: Low | 16 | 23 | 12 | 2 |
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.
| milliseconds (ms) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| PR Interval | 4.2 ± 14.4 | 2.5 ± 14.3 | 3.6 ± 15.6 | -2.0 ± 16.2 |
| QRS Duration | 1.6 ± 8.1 | 1.5 ± 7.8 | 0.8 ± 6.8 | 1.1 ± 10.1 |
| QT Interval | 4.8 ± 27.9 | 5.6 ± 28.0 | 1.3 ± 26.7 | 1.6 ± 27.8 |
| QTCB Interval | -0.9 ± 26.5 | -0.1 ± 25.2 | -0.8 ± 28.6 | 5.6 ± 20.5 |
| QTCF Interval | 1.1 ± 19.6 | 1.8 ± 20.8 | -0.1 ± 21.9 | 4.1 ± 16.4 |
| QTCN Interval | 0.7 ± 20.4 | 1.5 ± 21.2 | -0.3 ± 22.9 | 4.3 ± 16.6 |
| RR Interval | 26.9 ± 175.1 | 26.5 ± 146.1 | 10.0 ± 166.0 | -12.3 ± 147.7 |
Twelve-lead ECG recordings were obtained for parameters including mean heart rate.
| beats/min | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in ECG Parameters (Parameters Assessed in Beats Per Minute) | -2.1 ± 14.7 | -1.7 ± 13.3 | -0.8 ± 13.8 | 1.8 ± 13.6 |
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.
| Participants | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Bradycardia | 4 | 1 | 1 | 0 |
| Sinus Bradycardia | 4 | 1 | 1 | 0 |
| SVPB | 1 | 1 | 2 | 0 |
| VPB | 1 | 1 | 0 | 0 |
| 1° AV Block | 1 | 2 | 0 | 0 |
| RBBB | 1 | 0 | 1 | 0 |
| Sym T-Wave Inv | 0 | 0 | 0 | 1 |
| QT | 1 | 0 | 0 | 0 |
| Increase in QTcF | 0 | 1 | 0 | 0 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline on the Abnormal Involuntary Movement Scale (AIMS) Total Score | -0.01 ± 0.30 | -0.06 ± 0.35 | 0.09 ± 0.68 | -0.05 ± 0.22 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline on the Simpson-Angus Scale (SAS) Total Score | -0.18 ± 0.69 | -0.33 ± 0.77 | 0.17 ± 1.40 | -0.75 ± 2.38 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Mean Change From Baseline in the Barnes Akathisia Rating Scale (BARS) Total Score | -0.02 ± 0.29 | -0.08 ± 0.34 | 0.02 ± 0.53 | -0.15 ± 0.49 |
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.
| Participants | De Novo (Conversion Period) | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|---|
| Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS) | 0 | 5 | 4 | 6 | 1 |
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.
| Participants | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Psychic: Concentration Difficulties: NP | 38 | 30 | 32 | 2 |
| Psychic: Concentration Difficulties: Mild | 30 | 30 | 33 | 9 |
| Psychic: Concentration Difficulties: Moderate | 29 | 24 | 20 | 8 |
| Psychic: Concentration Difficulties: Severe | 1 | 5 | 2 | 1 |
| Psychic: Asthenia/Lassitude: NP | 59 | 49 | 44 | 5 |
| Psychic: Asthenia/Lassitude: Mild | 26 | 24 | 30 | 9 |
| Psychic: Asthenia/Lassitude: Moderate | 13 | 16 | 13 | 6 |
| Psychic: Sleepiness/Sedation: NP | 77 | 65 | 63 | 9 |
| Psychic: Sleepiness/Sedation: Mild | 16 | 20 | 23 | 10 |
| Psychic: Sleepiness/Sedation: Moderate | 5 | 4 | 1 | 1 |
| Psychic: Failing Memory, Degree: NP | 56 | 51 | 49 | 9 |
| Psychic: Failing Memory: Mild | 28 | 21 | 27 | 5 |
| Psychic: Failing Memory: Moderate | 14 | 17 | 11 | 6 |
| Psychic: Depression: NP | 60 | 49 | 46 | 7 |
| Psychic: Depression: Mild | 31 | 26 | 31 | 7 |
| Psychic: Depression: Moderate | 6 | 13 | 10 | 6 |
| Psychic: Depression: Severe | 1 | 1 | 0 | 0 |
| Psychic: Tension/Lnner Unrest: NP | 46 | 37 | 35 | 5 |
| Psychic: Tension/Lnner Unrest: Mild | 36 | 32 | 35 | 13 |
| Psychic: Tension/Lnner Unrest: Moderate | 15 | 20 | 15 | 1 |
| Psychic: Tension/Lnner Unrest: Severe | 1 | 0 | 2 | 1 |
| Psychic: Increased Duration Of Sleep: NP | 82 | 79 | 73 | 13 |
| Psychic: Increased Duration Of Sleep: Mild | 16 | 7 | 12 | 6 |
| Psychic: Increased Duration Of Sleep: Moderate | 0 | 3 | 2 | 1 |
| Psychic: Reduced Duration Of Sleep, Degree: NP | 88 | 69 | 68 | 12 |
| Psychic: Reduced Duration Of Sleep: Mild | 7 | 15 | 18 | 5 |
| Psychic: Reduced Duration Of Sleep: Moderate | 2 | 5 | 1 | 3 |
| Psychic: Reduced Duration Of Sleep: Severe | 1 | 0 | 0 | 0 |
| Psychic: Inc. Dream Activity: NP | 88 | 75 | 74 | 15 |
| Psychic: Inc. Dream Activity: Mild | 10 | 11 | 11 | 5 |
| Psychic: Inc. Dream Activity: Moderate | 0 | 3 | 2 | 0 |
| Psychic: Emotional Indifference: NP | 45 | 47 | 48 | 3 |
| Psychic: Emotional Indifference: Mild | 33 | 24 | 22 | 7 |
| Psychic: Emotional Indifference: Moderate | 20 | 17 | 15 | 10 |
| Psychic: Emotional Indifference: Severe | 0 | 1 | 2 | 0 |
| Neurologic: Dystonia: NP | 94 | 88 | 85 | 20 |
| Neurologic: Dystonia: Mild | 3 | 1 | 2 | 0 |
| Neurologic: Dystonia: Moderate | 1 | 0 | 0 | 0 |
| Neurologic: Rigidity: Not Present | 94 | 87 | 81 | 17 |
| Neurologic: Rigidity: Mild | 4 | 2 | 6 | 3 |
| Neurologic: Hypokinesia/Akinesia: NP | 93 | 85 | 82 | 19 |
| Neurologic: Hypokinesia/Akinesia: Mild | 5 | 4 | 4 | 1 |
| Neurologic: Hypokinesia/Akinesia: Moderate | 0 | 0 | 1 | 0 |
| Neurologic: Hyperkinesia Logic: NP | 96 | 89 | 85 | 20 |
| Neurologic: Hyperkinesia Logic: Mild | 1 | 0 | 2 | 0 |
| Neurologic: Hyperkinesia Logic: Moderate | 1 | 0 | 0 | 0 |
| Neurologic: Tremor: Not Present | 86 | 83 | 75 | 17 |
| Neurologic: Tremor: Mild | 11 | 5 | 10 | 3 |
| Neurologic: Tremor: Moderate | 1 | 1 | 2 | 0 |
| Neurologic: Akathisia: Not Present | 93 | 77 | 74 | 19 |
| Neurologic: Akathisia: Mild | 4 | 9 | 11 | 1 |
| Neurologic: Akathisia: Moderate | 1 | 3 | 2 | 0 |
| Neurologic: Epileptic Seizures: NP | 98 | 89 | 87 | 20 |
| Neurologic: Paraesthesias: NP | 98 | 87 | 85 | 20 |
| Neurologic: Paraesthesias: Mild | 0 | 2 | 2 | 0 |
| Auto:Accommodation Disturbances :NP | 98 | 87 | 85 | 16 |
| Auto: Accommodation Disturbances: Mild | 0 | 1 | 2 | 0 |
| Auto: Accommodation Disturbances: Moderate | 0 | 1 | 0 | 4 |
| Auto: Increased Salivation: Not Present | 95 | 84 | 81 | 20 |
| Auto: Increased Salivation: Mild | 3 | 4 | 3 | 0 |
| Auto: Increased Salivation: Moderate | 0 | 0 | 3 | 0 |
| Auto: Increased Salivation: Severe | 0 | 1 | 0 | 0 |
| Auto: Reduced Salivation: Not Present | 98 | 88 | 83 | 19 |
| Auto: Reduced Salivation: Mild | 0 | 1 | 4 | 1 |
| Auto: Nausea/Vomiting: Not Present | 93 | 86 | 76 | 19 |
| Auto: Nausea/Vomiting: Mild | 4 | 2 | 9 | 1 |
| Auto: Nausea/Vomiting: Moderate | 1 | 1 | 1 | 0 |
| Auto: Nausea/Vomiting: Severe | 0 | 0 | 1 | 0 |
| Auto: Diarrhoea: Not Present | 97 | 88 | 84 | 20 |
| Auto: Diarrhoea: Mild | 1 | 0 | 2 | 0 |
| Auto: Diarrhoea: Moderate | 0 | 1 | 1 | 0 |
| Auto: Constipation: Not Present | 95 | 87 | 85 | 17 |
| Auto: Constipation: Mild | 2 | 2 | 2 | 3 |
| Auto: Constipation: Moderate | 1 | 0 | 0 | 0 |
| Auto: Micturition Disturbances: NP | 97 | 88 | 85 | 20 |
| Auto: Micturition Disturbances: Mild | 1 | 1 | 1 | 0 |
| Auto: Micturition Disturbances: Moderate | 0 | 0 | 1 | 0 |
| Auto: Polyuria/Polydipsia: Not Present | 97 | 85 | 84 | 20 |
| Auto:Polyuria/Polydipsia, Degree:Mild | 0 | 4 | 1 | 0 |
| Auto:Polyuria/Polydipsia:Moderate | 1 | 0 | 2 | 0 |
| Auto:Orthostatic Dizziness: Not Present | 95 | 84 | 81 | 17 |
| Auto:Orthostatic Dizziness: Mild | 3 | 5 | 5 | 3 |
| Auto:Orthostatic Dizziness: Moderate | 0 | 0 | 1 | 0 |
| Auto:Palpitations/Tachycardia:Not Present | 94 | 85 | 82 | 17 |
| Auto:Palpitations/Tachycardia:Mild | 3 | 4 | 3 | 3 |
| Auto:Palpitations/Tachycardia:Moderate | 1 | 0 | 1 | 0 |
| Auto:Palpitations/Tachycardia:Severe | 0 | 0 | 1 | 0 |
| Auto:Inc. Tendency To Sweat:NP | 84 | 19 | 84 | 19 |
| Auto:Inc. Tendency To Sweat:Mild | 2 | 1 | 3 | 1 |
| Auto:Inc. Tendency To Sweat:Moderate | 0 | 0 | 0 | 0 |
| Auto:Inc. Tendency To Sweat:Severe | 1 | 0 | 1 | 0 |
| Other:Rash:Not Present | 98 | 89 | 87 | 20 |
| Other:Morbilliform: Mild | 2 | 0 | 0 | 0 |
| Other:Petechial: Mild | 2 | 0 | 0 | 0 |
| Other: Urticarial: Mild | 2 | 0 | 1 | 0 |
| Other:Psoriatic: Mild | 2 | 0 | 0 | 0 |
| Other:Cannot Be Classified: Mild | 2 | 0 | 1 | 1 |
| Other:Pruritus, Degree: Not Present | 98 | 87 | 85 | 20 |
| Other:Pruritus: Mild | 0 | 1 | 1 | 0 |
| Other:Pruritus: Moderate | 0 | 1 | 1 | 0 |
| Other:Photosensitivity: Not Present | 97 | 86 | 86 | 20 |
| Other:Photosensitivity : Mild | 1 | 3 | 1 | 0 |
| Other:Inc. Pigmentation: NP | 98 | 89 | 87 | 20 |
| Other:Weight Gain: Not Present | 74 | 66 | 67 | 11 |
| Other:Weight Gain: Mild | 16 | 15 | 15 | 6 |
| Other:Weight Gain: Moderate | 18 | 6 | 5 | 3 |
| Other:Weight Gain: Severe | 0 | 2 | 0 | 0 |
| Other:Weight Loss: Not Present | 80 | 77 | 76 | 15 |
| Other:Weight Loss: Mild | 15 | 11 | 9 | 5 |
| Other:Weight Loss: Moderate | 3 | 1 | 2 | 0 |
| Other: Menorrhagia: NP | 70 | 64 | 61 | 16 |
| Other:Menorrhagia:Mild | 0 | 1 | 1 | 0 |
| Other:Menorrhagia:Severe | 0 | 0 | 1 | 0 |
| Other: Amenorrhoea: NP | 68 | 58 | 57 | 14 |
| Other:Amenorrhoea:Mild | 1 | 1 | 1 | 0 |
| Other:Amenorrhoea: Moderate | 0 | 1 | 0 | 0 |
| Other:Amenorrhoea:Severe | 0 | 1 | 0 | 0 |
| Other:Galactorrhoea : Not Present | 88 | 78 | 75 | 20 |
| Other:Galactorrhoea : Mild | 0 | 1 | 0 | 0 |
| Other: Gynaecomastia: NP | 77 | 70 | 70 | 17 |
| Other: Inc. Sexual Desire: Not Present | 91 | 84 | 83 | 19 |
| Other: Inc. Sexual Desire: Mild | 0 | 1 | 2 | 1 |
| Other: Inc. Sexual Desire: Moderate | 1 | 0 | 0 | 0 |
| Other:Diminished Sexual Desire: NP | 91 | 80 | 81 | 14 |
| Other:Diminished Sexual Desire: Mild | 1 | 5 | 2 | 5 |
| Other:Diminished Sexual Desire: Moderate | 0 | 0 | 2 | 0 |
| Other:Diminished Sexual Desire: Severe | 0 | 0 | 0 | 1 |
| Other:Erectile Dysfunction: NP | 66 | 53 | 63 | 10 |
| Other:Erectile Dysfunction: Mild | 0 | 3 | 0 | 2 |
| Other:Ejaculatory Dysfunction:Not Present | 65 | 54 | 62 | 12 |
| Other:Ejaculatory Dysfunction:Mild | 0 | 1 | 0 | 0 |
| Other:Ejaculatory Dysfunction:Moderate | 0 | 1 | 0 | 0 |
| Other:Orgastic Dysfunction: NP | 88 | 83 | 82 | 19 |
| Other:Orgastic Dysfunction: Mild | 0 | 1 | 1 | 1 |
| Other : Dry Vagina, Degree : Not Present | 67 | 66 | 62 | 14 |
| Other: Headache : Not Present | 98 | 89 | 87 | 20 |
| Other:Tension Headache: Mild | 2 | 4 | 5 | 3 |
| Other:Tension Headache: Moderate | 2 | 0 | 0 | 1 |
| Other:Migraine: Mild | 3 | 2 | 5 | 0 |
| Other:Other Forms: Mild | 3 | 1 | 5 | 0 |
| Other:Other Forms: Moderate | 0 | 1 | 83 | 13 |
| Other:Physical Dependence:NP | 93 | 83 | 83 | 13 |
| Other:Physical Dependence:Mild | 0 | 0 | 0 | 1 |
| Other:Physical Dependence:Moderate | 0 | 0 | 0 | 2 |
| Other:Psychic Dependence: NP | 98 | 88 | 86 | 17 |
| Other:Psychic Dependence:Mild | 0 | 0 | 1 | 1 |
| Other:Psychic Dependence:Moderate | 0 | 0 | 0 | 2 |
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.
| Participants | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Working Memory | 69 | 57 | 61 | 14 |
| Attention/Vigilance | 77 | 72 | 69 | 17 |
| Verbal Learning | 59 | 46 | 51 | 17 |
| Visual Learning | 35 | 33 | 35 | 5 |
| Reasoning | 76 | 69 | 65 | 18 |
| Speed of Processing | 72 | 59 | 59 | 15 |
| Social Cognition | 77 | 71 | 64 | 17 |
| Any Sign/Symptoms | 88 | 78 | 74 | 20 |
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.
| Participants | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Boys: Baseline-Stage 1 | 0 | 0 | 0 | 0 |
| Boys: Baseline-Stage 2 | 4 | 3 | 0 | 0 |
| Boys: Baseline-Stage 3 | 7 | 5 | 5 | 3 |
| Boys: Baseline-Stage 4 | 14 | 21 | 16 | 7 |
| Boys: Baseline-Stage 5 | 20 | 11 | 24 | 1 |
| Boys: Month 24-Stage 1 | 0 | 0 | 0 | 0 |
| Boys: Month 24-Stage 2 | 0 | 0 | 0 | 0 |
| Boys: Month 24-Stage 3 | 2 | 2 | 1 | 0 |
| Boys: Month 24-Stage 4 | 9 | 13 | 8 | 2 |
| Boys: Month 24-Stage 5 | 18 | 13 | 15 | 4 |
| Girls: Baseline-Stage 1 | 0 | 0 | 0 | 0 |
| Girls: Baseline-Stage 2 | 0 | 1 | 0 | 0 |
| Girls: Baseline-Stage 3 | 8 | 3 | 6 | 1 |
| Girls: Baseline-Stage 4 | 17 | 21 | 16 | 8 |
| Girls: Baseline-Stage 5 | 28 | 24 | 20 | 0 |
| Girls: Month 24- Stage 1 | 0 | 0 | 0 | 0 |
| Girls: Month 24-Stage 2 | 0 | 0 | 0 | 0 |
| Girls: Month 24-Stage 3 | 0 | 0 | 0 | 0 |
| Girls: Month 24-Stage 4 | 5 | 9 | 9 | 1 |
| Girls: Month 24-Stage 5 | 22 | 21 | 18 | 4 |
Results for this outcome have not been posted.
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Change From Baseline in the PANSS Total Score | -18.44 ± 17.53 | -20.14 ± 17.63 | -19.76 ± 18.88 | -19.00 ± 13.61 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Change From Baseline in the PANSS Positive Subscale Scores | -4.59 ± 5.11 | -5.20 ± 5.08 | -5.29 ± 5.75 | -5.15 ± 4.97 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) |
|---|---|---|---|---|
| Change From Baseline in the PANSS Negative Subscale Scores | -4.82 ± 5.46 | -4.89 ± 4.98 | -4.55 ± 5.37 | -4.40 ± 4.11 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole (Open-label Treatment Period) | Prior Placebo (Open-label Treatment Period) | De Novo (Open-label Treatment Period) |
|---|---|---|---|---|
| Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score | 13.58 ± 13.26 | 14.31 ± 14.13 | 12.92 ± 13.42 | 23.05 ± 12.80 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole (Open-label Treatment Period) | Prior Placebo (Open-label Treatment Period) | De Novo (Open-label Treatment Period) |
|---|---|---|---|---|
| Mean Clinical Global Impression Severity (CGI-S) Scale Score | -1.09 ± 1.16 | -1.11 ± 1.20 | -0.86 ± 1.21 | -1.30 ± 1.08 |
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.
| score on a scale | Prior & Current Brexpiprazole (OLT Period) | Prior Aripiprazole (Open-label Treatment Period) | Prior Placebo (Open-label Treatment Period) | De Novo (Open-label Treatment Period) |
|---|---|---|---|---|
| Mean Clinical Global Impression - Improvement (CGI-I) Scale Score | 2.1 ± 1.2 | 2.1 ± 1.1 | 2.2 ± 1.1 | 1.9 ± 1.1 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prior and Current Brexpiprazole | 0/98 (0%) | 4/98 (4.1%) | 45/98 (45.9%) |
| Prior Aripiprazole & Current Brexpiprazole (OLT Period) | 0/89 (0%) | 1/89 (1.1%) | 37/89 (41.6%) |
| Prior Placebo & Current Brexpiprazole (OLT Period) | 0/87 (0%) | 3/87 (3.4%) | 42/87 (48.3%) |
| De Novo (OLT Period) | 0/20 (0%) | 1/20 (5%) | 13/20 (65%) |
| De Novo (Conversion Period) | 0/14 (0%) | 0/14 (0%) | 5/14 (35.7%) |
| Event | Prior and Current Brexpiprazole | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) | De Novo (Conversion Period) |
|---|---|---|---|---|---|
| Suicidal IdeationPsychiatric disorders | 0/98 | 0/89 | 0/87 | 1/20 | 0/14 |
| Psychotic DisorderPsychiatric disorders | 1/98 | 0/89 | 1/87 | 0/20 | 0/14 |
| SchizophreniaPsychiatric disorders | 1/98 | 1/89 | 1/87 | 0/20 | 0/14 |
| Suicide AttemptPsychiatric disorders | 1/98 | 0/89 | 1/87 | 0/20 | 0/14 |
| Abnormal Sensation in EyeEye disorders | 1/98 | 0/89 | 0/87 | 0/20 | 0/14 |
| Pilonidal DiseaseInfections and infestations | 1/98 | 0/89 | 0/87 | 0/20 | 0/14 |
| Psychomotor HyperactivityNervous system disorders | 1/98 | 0/89 | 0/87 | 0/20 | 0/14 |
| Event | Prior and Current Brexpiprazole | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) | De Novo (Conversion Period) |
|---|---|---|---|---|---|
| SomnolenceNervous system disorders | 9/98 | 7/89 | 9/87 | 6/20 | 2/14 |
| Weight IncreasedInvestigations | 7/98 | 12/89 | 9/87 | 4/20 | 0/14 |
| IrritabilityPsychiatric disorders | 0/98 | 0/89 | 0/87 | 0/20 | 2/14 |
| HeadacheNervous system disorders | 10/98 | 9/89 | 11/87 | 0/20 | 0/14 |
| InfluenzaInfections and infestations | 4/98 | 5/89 | 0/87 | 2/20 | 0/14 |
| Coronavirus Test PositiveInvestigations | 0/98 | 0/89 | 0/87 | 2/20 | 0/14 |
| Muscle RigidityMusculoskeletal and connective tissue disorders | 0/98 | 0/89 | 4/87 | 2/20 | 0/14 |
| InsomniaPsychiatric disorders | 1/98 | 4/89 | 8/87 | 1/20 | 1/14 |
| NasopharyngitisInfections and infestations | 9/98 | 6/89 | 4/87 | 0/20 | 0/14 |
| AkathisiaNervous system disorders | 6/98 | 4/89 | 4/87 | 1/20 | 1/14 |
The enrolled sample consists of all consented/assented participants who were screened for eligibility and deemed eligible.
| Age, Continuous(years) | Prior and Current Brexpiprazole | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) | Total |
|---|---|---|---|---|---|
| Mean | 15.5 ± 1.6 | 15.5 ± 1.4 | 15.4 ± 1.5 | 15.5 ± 1.0 | 15.5 ± 1.5 |
| Sex: Female, Male(Participants) | Prior and Current Brexpiprazole | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) | Total |
|---|---|---|---|---|---|
| Female | 53 | 49 | 42 | 9 | 153 |
| Male | 46 | 40 | 45 | 11 | 142 |
| Race/Ethnicity, Customized(Participants) | Prior and Current Brexpiprazole | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) | Total |
|---|---|---|---|---|---|
| Race — White | 65 | 64 | 58 | 18 | 205 |
| Race — Black or African American | 6 | 2 | 3 | 1 | 12 |
| Race — American Indian or Alaska Native | 2 | 1 | 4 | 0 | 7 |
| Race — Asian | 1 | 1 | 0 | 0 | 2 |
| Race — Native Hawaiin or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Race — Other | 25 | 21 | 21 | 1 | 68 |
| Race — Missing | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Prior and Current Brexpiprazole | Prior Aripiprazole & Current Brexpiprazole (OLT Period) | Prior Placebo & Current Brexpiprazole (OLT Period) | De Novo (OLT Period) | Total |
|---|---|---|---|---|---|
| Ethnicity — Hispanic or Latino | 29 | 25 | 30 | 1 | 85 |
| Ethnicity — Not Hispanic or Latino | 69 | 64 | 55 | 19 | 207 |
| Ethnicity — Other | 1 | 0 | 1 | 0 | 2 |
| Ethnicity — Unknown | 0 | 0 | 0 | 0 | 0 |
| Ethnicity — Missing | 0 | 0 | 1 | 0 | 1 |
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