Phase 3
N=14
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT03238326 ↗Enrolled (actual)
14
Serious AEs
2.9%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 5; 58; 54; 63 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
5; 58; 54; 63; 13 | — |
| PRIMARY Number of Participants With Serious Treatment Emergent Adverse Events (TEAEs) |
0; 4; 1; 3; 1 | — |
| PRIMARY Number of Participants Who Discontinued the Trial Due to AEs |
0; 4; 2; 3; 0 | — |
| SECONDARY Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Units Per Liter) |
0.02; 2.09; 0.60; -2.30; -0.43; 0.12 | — |
| SECONDARY Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milligrams Per Deciliter) |
0.04; 0.02; -0.05; -0.02; -0.07; -0.16 | — |
| SECONDARY Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Percentage) |
0.01; -0.01; 0.05; -0.05 | — |
| SECONDARY Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Million Cells Per Microliter) |
0.09; 0.06; 0.06; 0.01 | — |
| SECONDARY Mean Change From Baseline in Clinical Laboratory Tests (Parameters Assessed in Thousand Cells Per Microliter) |
0.00; -0.01; -0.01; 0.01; 0.02; 0.02 | — |
| SECONDARY Mean Change From Baseline in Laboratory Tests (Parameters That Were Unitless) |
0.04; -0.06; 0.03; 0.05 | — |
| SECONDARY Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Nanograms Per Milliliter) |
-8.34; 9.86; 6.07; -1.73; 0.83; 7.70 | — |
| SECONDARY Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milliequivalents Per Liter) |
0.16; -0.35; 0.19; 0.45; 0.02; -0.09 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests |
1; 1; 0; 1; 2; 0 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Parameters Assessed in Beats Per Minute) |
-0.6; -1.9; -0.5; -2.8; 1.1; -1.6 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Parameters Assessed in Millimeters of Mercury) |
0.7; 0.5; 1.5; -1.7; 0.7; 0.4 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Parameters Assessed in Centimeters) |
1.4; 2.4; 2.0; 3.5 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms) |
3.8; 4.2; 3.8; 3.4 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Parameters Assessed in Celsius) |
-0.0; -0.0; -0.0; 0.0 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Parameters Assessed in Z-Score) |
-0.0; -0.0; 0.0; 0.0; -0.1; 0.1 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Parameters Assessed in Kilograms Per Meter Square) |
1.0; 0.9; 0.8; 0.1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
7; 5; 6; 0; 10; 11 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) (Parameters Assessed in Milliseconds) |
4.2; 2.5; 3.6; -2.0; 1.6; 1.5 | — |
| SECONDARY Mean Change From Baseline in ECG Parameters (Parameters Assessed in Beats Per Minute) |
-2.1; -1.7; -0.8; 1.8 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in ECG Parameters |
4; 1; 1; 0; 4; 1 | — |
| SECONDARY Mean Change From Baseline on the Abnormal Involuntary Movement Scale (AIMS) Total Score |
-0.01; -0.06; 0.09; -0.05 | — |
| SECONDARY Mean Change From Baseline on the Simpson-Angus Scale (SAS) Total Score |
-0.18; -0.33; 0.17; -0.75 | — |
| SECONDARY Mean Change From Baseline in the Barnes Akathisia Rating Scale (BARS) Total Score |
-0.02; -0.08; 0.02; -0.15 | — |
| 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) |
0; 5; 4; 6; 1 | — |
| SECONDARY Number of Participants With Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale |
38; 30; 32; 2; 30; 30 | — |
| 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) |
69; 57; 61; 14; 77; 72 | — |
| SECONDARY Number of Participants With Stages of Tanner Scale Score at Baseline and Month 24 |
0; 0; 0; 0; 4; 3 | — |
| SECONDARY Change From Baseline in the PANSS Total Score |
-18.44; -20.14; -19.76; -19.00 | — |
| SECONDARY Change From Baseline in the PANSS Positive Subscale Scores |
-4.59; -5.20; -5.29; -5.15 | — |
| SECONDARY Change From Baseline in the PANSS Negative Subscale Scores |
-4.82; -4.89; -4.55; -4.40 | — |
| SECONDARY Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score |
13.58; 14.31; 12.92; 23.05 | — |
| SECONDARY Mean Clinical Global Impression Severity (CGI-S) Scale Score |
-1.09; -1.11; -0.86; -1.30 | — |
| SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Scale Score |
2.1; 2.1; 2.2; 1.9 | — |
Summary
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
Eligibility Criteria
Inclusion Criteria
- Male & female subjects 13-17 years of age, inclusive.
- Subjects who turn 18 during trial 331-10-234 are permitted in this trial.
- Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening.
- Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s).
Exclusion Criteria
- Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening
- Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use).
- History of failure of clozapine treatment or response to clozapine treatment only.
- History of neuroleptic malignant syndrome
Data sourced from ClinicalTrials.gov (NCT03238326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.