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Completed Phase 2 Interventional Results available

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

ClinicalTrials.gov ID: NCT00905307

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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 4:56 PM EDT

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

Interventions

Drug

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
Jul 2009 (Type not available)
Primary completion
Sep 2010 (Actual)
Completion
Nov 2010 (Actual)
Last update posted
Oct 20, 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 20, 2015 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00905307 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →