Phase 3
Completed N=406
Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
Acute Schizophrenia
Source: ClinicalTrials.gov NCT01668797 ↗
Enrolled (actual)
406
Serious AEs
7.2%
Results posted
Jan 2017
Primary outcomePrimary: Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. — 0.292; 3.420 Days — p=<0.0001
◆ Published Evidence
Established
91citations · ~10 / year
Efficacy and Safety of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults with Schizophrenia: a Randomized, Double-Blind, Placebo-Controlled Study.
Summary
The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.
Linked Publications (4)
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Efficacy and Safety of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults with Schizophrenia: a Randomized, Double-Blind, Placebo-Controlled Study.
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Successful switching of patients with acute schizophrenia from another antipsychotic to brexpiprazole: comparison of clinicians' choice of cross-titration schedules in a post hoc analysis of a randomized, double-blind, maintenance treatment study.
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Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies.
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Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: <i>Post Hoc</i> Analysis of Short- and Long-Term Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. |
0.292; 3.420 | <0.0001 sig |
| SECONDARY Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria in the Double-blind Maintenance Phase |
13.54; 38.46 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
- Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
- Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
- Subjects who showed previous response to antipsychotic treatment in the past year.
- Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
- Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
- Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
Exclusion Criteria
- Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
- Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
- Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
- Subjects experiencing acute depressive symptoms within the past 30 days
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
- Subjects with a significant risk of violent behavior; who represent a risk of committing suicide
- Subjects with clinically significant tardive dyskinesia
- Subjects currently treated with insulin for diabetes.
Data sourced from ClinicalTrials.gov (NCT01668797) and the linked publication. 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. Informational only — not medical advice.