Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | November 2010 |
A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizophrenia
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 subjects hospitalized with an acute relapse of schizophrenia.
Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay
sensitivity of the study. A total of approximately 563 subjects will be screened at an
estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.
assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the
treatment of adult subjects hospitalized with an acute relapse of schizophrenia.
Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay
sensitivity of the study. A total of approximately 563 subjects will be screened at an
estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.
Inclusion Criteria:
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
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
- 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 inclusion/exclusion criteria may apply
We found this trial at
16
sites
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