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

NCT ID: NCT02054702

Last Updated: 2015-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

Brief 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

Conditions

Schizophrenia

Keywords

Schizophrenia; Mental Disorders; Psychotic Disorders; Antipsychotic; Cognitive testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brexpiprazole

Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally

Group Type: EXPERIMENTAL

Brexpiprazole

Intervention Type: DRUG

Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally

Aripiprazole

Aripiprazole - Up to 20 mg/day, once daily dose, tablets, orally

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Up to 20 mg/day, once daily dose, tablets, orally

Interventions

Brexpiprazole

Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally

Intervention Type: DRUG

Aripiprazole

Up to 20 mg/day, once daily dose, tablets, orally

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junichi Hashimoto, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

Other Identifiers

331-13-008

Identifier Type: -

Identifier Source: org_study_id