Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

Conditions: Acute Schizophrenia
MedDRA version: 14.1Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2011-002538-38-LV

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 630

Inclusion Criteria

1.Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
2.Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3.Subjects experiencing an acute exacerbation of psychotic symptoms
4.Other protocol specific inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 660
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
2.Subjects with a current DSM-IV-TR Axis I diagnosis of:

?Schizoaffective disorder
?Major depressive disorder (MDD)
?Bipolar disorder
?Delirium, dementia, amnestic or other cognitive disorder
?Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3.Subjects presenting with a first episode of schizophrenia
4.Other protocol specific exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of each of three fixed doses<br>of OPC-34712 with placebo in the treatment of acute<br>schizophrenia in adults.;Secondary Objective: To compare the safety and tolerability of each of<br>three fixed doses of OPC-34712 with placebo in the treatment<br>of acute schizophrenia in adults.;Primary end point(s): •The change in Positive and Negative Syndrome Scale (PANSS) Total Score ;Timepoint(s) of evaluation of this end point: Baseline visit to Week 6/Early Termination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in Clinical Global Impression - Severity of Illness scale (CGI-S) score;Timepoint(s) of evaluation of this end point: Baseline visit to Week 6/Early Termination