Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia.
- Conditions
- Health Condition 1: null- SchizophreniaHealth Condition 2: F209- Schizophrenia, unspecified
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
1.Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by 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
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:
oSchizoaffective disorder
oMDD
oBipolar disorder
oDelirium, dementia, amnestic or other cognitive disorder
oBorderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3.Subjects presenting with a first episode of schizophrenia
4.Other protocol specific inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of the study is to establish the optimal dose of OPC-34712 for the treatment of acute schizophrenia based on efficacy, safety, and tolerability during a 6-week treatment period.Timepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI