A dose-finding trial of OPC-34712 in patients with schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia

• Registration Number: JPRN-jRCT2080221591
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

Brexpiprazole exerted a therapeutic effect on patients in the acute phase of schizophrenia. While vomiting, blood prolactin increased, diarrhoea, nausea, and dental caries occurred in the brexpiprazole groups at an incidence of 5% or higher and at more than double the incidence in the placebo group, all cases were non-serious and had no effect on the continuation of IMP administration. There were no clinically meaningful marked changes in laboratory values, vital signs, body weight, or ECG.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Study Completion: 2015-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
- Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
- Patients who are experiencing acute exacerbation of psychotic symptoms

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 I criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

Secondary Outcome Measures

Name	Time	Method
efficacy<br>1.Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.<br>2.Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. <br>3.Change in CGI-S Score from Baseline to Week 6<br>4.CGI-I Score at Week 6<br><br><br><br>safety<br>Percentage of Participants With Treatment-emergent adverse event(TEAE)