Phase 3
N=97
Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02054702 ↗Enrolled (actual)
97
Serious AEs
4.1%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score — -22.9; -19.4 Units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug); Aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-22.9; -19.4 | <0.0001 sig |
| SECONDARY Change From Baseline in Cognitive Test Battery Composite Score |
0.045; -0.024 | 0.4244 |
| SECONDARY Change From Baseline in Cognitive Test Battery of Early Phase Battery Score |
-0.010; 0.113 | 0.8759 |
| SECONDARY Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML) |
0.7; -4.6 | 0.8420 |
| SECONDARY Change From Baseline in Cognitive Test Battery Scores of Detection Task |
0.024; -0.029 | 0.1807 |
| SECONDARY Change From Baseline in Cognitive Test Battery Scores of Identification Task |
-0.002; -0.011 | 0.8622 |
| SECONDARY Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task |
0.003; 0.000 | 0.8588 |
| SECONDARY Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score |
-1.6; -1.3 | <0.0001 sig |
| SECONDARY Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6 |
2.5; 2.7 | — |
| SECONDARY Response Rate by Study Week |
60.9; 48.5 | — |
| SECONDARY Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score |
7.5; 6.0 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score |
-2.6; -0.1 | 0.0392 sig |
Summary
The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia
Eligibility Criteria
Inclusion Criteria
- 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
- Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
- Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
- Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
- Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
- Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)
Exclusion Criteria
- Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
- Have been hospitalized > 21 days for the current acute episode at the time of the baseline visit
- Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
- Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.
Data sourced from ClinicalTrials.gov (NCT02054702). 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.