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

NCT02054702 | Completed Phase 3 Results

• 1 other identifier: 331-13-008
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

  Baseline to Week 6

Secondary Outcomes (11)

• Change From Baseline in Cognitive Test Battery Composite Score

  Baseline to Week 6

• Change From Baseline in Cognitive Test Battery of Early Phase Battery Score

  Baseline to Week 6

• Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)

  Baseline to Week 6

• Change From Baseline in Cognitive Test Battery Scores of Detection Task

  Baseline to Week 6

• Change From Baseline in Cognitive Test Battery Scores of Identification Task

  Baseline to Week 6

Study Arms (2)

Brexpiprazole

EXPERIMENTAL

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

Drug: Brexpiprazole

Aripiprazole

EXPERIMENTAL

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

Drug: Aripiprazole

Interventions

Brexpiprazole DRUG

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

Brexpiprazole

Aripiprazole DRUG

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

Aripiprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders

Interventions

brexpiprazole; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Junichi Hashimoto, PhD

  Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 30, 2015
• Results First Posted: December 1, 2015

Record last verified: 2015-12