Phase 3
N=316
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT03198078 ↗Enrolled (actual)
316
Serious AEs
1.6%
Results posted
Dec 2023
Primary outcome: Primary: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score — -22.75; -23.95; -17.42 score on a scale — p=0.0136
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (OPC-34712) (Drug); Aripiprazole (Drug); Placebo (Drug)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-22.75; -23.95; -17.42 | 0.0136 sig |
| SECONDARY Change From Baseline to Week 6 in PANSS Positive and Negative Sub-Scales Scores |
-6.58; -7.29; -5.14; -4.70; -4.77; -3.82 | 0.0205 sig |
| SECONDARY Percentage of Participants Achieving Response |
43.64; 43.56; 28.16 | 0.0111 sig |
| SECONDARY Percentage of Participants Achieving Remission |
29.09; 35.64; 23.30 | 0.4415 |
| SECONDARY Change From Baseline to Week 6 in Children's Global Assessment Scale (CGAS) Total Score |
10.56; 12.07; 8.08 | 0.0854 |
| SECONDARY Change From Baseline to Week 6 in Clinical Global Impression Severity (CGI-S) Scale Score |
-0.92; -1.01; -0.80 | 0.3589 |
| SECONDARY Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 6 |
2.86; 2.79; 3.17 | 0.0287 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) and Trial Discontinuation Due to AEs |
46; 56; 44; 0; 1; 2 | — |
| SECONDARY Number of Participants With Treatment-emergent AEs (TEAEs), Serious TEAEs, and TEAEs Graded by Severity |
44; 53; 42; 1; 1; 3 | — |
| SECONDARY Mean Change From Baseline in Weight |
0.8; 0.5; 0.0 | — |
| SECONDARY Mean Change From Baseline in Height |
0.2; 0.2; 0.3 | — |
| SECONDARY Mean Change From Baseline in Body Mass Index (BMI) |
0.2; 0.3; 0.0 | — |
| SECONDARY Mean Change From Baseline in Waist Circumference |
0.6; -0.3; 0.0 | — |
| 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) |
1; 2; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Laboratory Test Values |
1; 2; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs |
0; 0; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score |
0.04; 0.15; -0.03 | — |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score |
-0.12; 0.05; -0.06 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score |
0.01; 0.06; 0.01 | — |
| SECONDARY Number of Participants With Severe Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale |
7; 10; 8; 6; 3; 1 | — |
| SECONDARY Number of Participants With Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) |
88; 79; 83; 98; 90; 91 | — |
Summary
To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
- PANSS score >= 80, inclusive, at screening and baseline
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 who have been hospitalized > 21 days for a current exacerbation of schizophrenia at the time of baseline.
- Any neurological disorder other than Tourette's Syndrome
- Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
- Subjects with epilepsy, a history of seizures, severe head trauma or stroke
- Subjects who test positive for drugs of abuse at screening
Data sourced from ClinicalTrials.gov (NCT03198078). 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.