Status:
COMPLETED
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjec...
Eligibility Criteria
Inclusion
- Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
- Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
- Subjects experiencing an acute exacerbation of psychotic symptoms
Exclusion
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
- Subjects with a current DSM-IV-TR Axis I diagnosis of:
- Schizoaffective disorder
- MDD
- Bipolar disorder
- Delirium, dementia, amnestic or other cognitive disorder
- Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
- Subjects presenting with a first episode of schizophrenia
- Other protocol specific inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT00905307
Start Date
July 1 2009
End Date
November 1 2010
Last Update
October 20 2015
Active Locations (73)
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1
Study Site
Little Rock, Arkansas, United States, 72211
2
Study Site
Escondido, California, United States, 92025
3
Study Site
Garden Grove, California, United States, 92645
4
Study Site
Long Beach, California, United States, 90813