Phase 3
N=49
Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02013622 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score — -10.2 Units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-10.2 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking |
-2.0 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score |
-0.6 | <0.0001 sig |
| SECONDARY Mean Clinical Global Impression-Improvement (CGI-I) Score |
3.6; 3.1; 2.7; 2.8; 2.7; 2.9 | — |
| SECONDARY CGI-I Response Rate |
39.6; 35.4; 41.7; 41.7 | — |
| SECONDARY Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score |
6.6 | 0.0003 sig |
| SECONDARY Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score |
13.1 | 0.0002 sig |
| SECONDARY Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score |
-1.8 | 0.0177 sig |
| SECONDARY Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score |
20.00; 10.25; 11.83; 20.67 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures) |
0.045; 0.066 | 0.5133 |
| SECONDARY Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time) |
-2.05; -18.77 | 0.8897 |
| SECONDARY Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores |
0.008520 | 0.4265 |
| SECONDARY Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores |
-103.167142; 2.866008 | 0.2923 |
| SECONDARY Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT) |
8.9 | 0.1815 |
| SECONDARY Mean Change From Baseline to Week 16 in Food Delay Discounting Task |
0.037 | 0.6648 |
| SECONDARY Mean Change From Baseline to Week 16 in Money Delay Discounting Task |
0.001 | — |
| SECONDARY Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item |
-4.8 | 0.0306 sig |
Summary
The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as episodes occurring ≤ 5 years after the onset of the first episode.
Eligibility Criteria
Inclusion Criteria: Have 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 both the Mini International Neuropsychiatric Interview (M.I.N.I.) for Schizophrenia and Psychotic Disorders Studies and an adequate clinical psychiatric evaluation.
- Had the start of their first schizophrenia episode ≤ 5 years before the time of consent.
- Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).
- Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening and baseline.
- Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking.
- Have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history.
Exclusion Criteria: Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.
- Subjects who have been hospitalized for psychotic symptoms within the last 6 months.
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.
- Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.
- Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
- Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of>= 3 on Item 8 of the AIMS at screening or baseline.
- Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
- Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.
Data sourced from ClinicalTrials.gov (NCT02013622). 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.