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

Otsuka Pharmaceutical Development & Commercialization, Inc.0 sites97 target enrollmentFebruary 2014

ConditionsSchizophrenia

InterventionsBrexpiprazole Aripiprazole

DrugsBrexpiprazole Aripiprazole

Overview

Phase: Phase 3
Intervention: Brexpiprazole
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 97
Primary Endpoint: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Sponsor

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.

Arms & Interventions

Brexpiprazole

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

Intervention: Brexpiprazole

Aripiprazole

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

Intervention: Aripiprazole

Outcomes

Primary Outcomes

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

Time Frame: Baseline to Week 6

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).

Secondary Outcomes

Change From Baseline in Cognitive Test Battery Scores of Identification Task(Baseline to Week 6)
Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6(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 One Card Learning Task(Baseline to Week 6)
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)
Response Rate by Study Week(Baseline to Week 6)
Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)(Baseline to Week 6)
Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score(Baseline to Week 6)
Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score(Baseline to Week 6)
Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score(Baseline to Week 6)