Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
Public ClinicalTrials.gov record NCT00905307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00905307
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 459 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2009
- Primary completion
- Aug 31, 2010
- Completion
- Oct 31, 2010
- Last update posted
- Oct 19, 2015
2009 – 2010
United States locations
- U.S. sites
- 16
- U.S. states
- 8
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | Little Rock | Arkansas | 72211 | — |
| Study Site | Escondido | California | 92025 | — |
| Study Site | Garden Grove | California | 92645 | — |
| Study Site | Long Beach | California | 90813 | — |
| Study Site | Oceanside | California | 92056 | — |
| Study Site | Pasadena | California | 91107 | — |
| Study Site | San Diego | California | 92102 | — |
| Study Site | San Diego | California | 92123 | — |
| Study Site | Santa Ana | California | 92701 | — |
| Study Site | Washington D.C. | District of Columbia | 20016 | — |
| Study Site | Bradenton | Florida | 34208 | — |
| Study Site | Maitland | Florida | 32751 | — |
| Study Site | St Louis | Missouri | 63118 | — |
| Study Site | Cedarhurst | New York | 11516 | — |
| Study Site | Philadelphia | Pennsylvania | 19139 | — |
| Study Site | Austin | Texas | 78756 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00905307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2015 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00905307 live on ClinicalTrials.gov.