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Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia | Clinical Trials | Clareo Health

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Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia

NCT02054702•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

February 1, 2014

Primary Completion Date

June 1, 2014

Completion Date

July 1, 2014

Last Updated

December 30, 2015

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

Brexpiprazole

DRUG

Aripiprazole

DRUG

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NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

Inclusion Criteria

Exclusion Criteria

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