Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

ClinicalTrials.gov ID: NCT01396421

Public ClinicalTrials.gov record NCT01396421. 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.

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ClinicalTrials.gov public records Last synced Jul 24, 2026, 8:08 AM 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 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

Study identification

NCT ID: NCT01396421
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 636 participants

Conditions and interventions

Conditions

Acute Schizophrenia

Interventions

OPC-34712 [Brexpiprazole] High Dose Drug
Experimental: OPC-34712 [Brexpiprazole] Middle Dose Drug
Experimental: OPC-34712 [Brexpiprazole] Low Dose Drug
Placebo Drug

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: Jun 30, 2011
Primary completion: Dec 31, 2013
Completion: Dec 31, 2013
Last update posted: Oct 28, 2015

2011 – 2014

United States locations

U.S. sites: 17
U.S. states: 8
U.S. cities: 15

Facility	City	State	ZIP	Site status
Not listed	Little Rock	Arkansas	72205	—
Not listed	Garden Grove	California	92845	—
Not listed	Glendale	California	91206	—
Not listed	Oakland	California	94612	—
Not listed	Oceanside	California	92056	—
Not listed	San Diego	California	92102	—
Not listed	San Diego	California	92123	—
Not listed	Bradenton	Florida	34208	—
Not listed	Miami Springs	Florida	33166	—
Not listed	Orlando	Florida	32806	—
Not listed	Fresh Meadows	New York	11423	—
Not listed	Jamaica	New York	11432	—
Not listed	Dayton	Ohio	45417	—
Not listed	Charleston	South Carolina	29405	—
Not listed	Charleston	South Carolina	29407	—
Not listed	Austin	Texas	78754	—
Not listed	Kirkland	Washington	98033	—

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 43 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01396421, 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 28, 2015 · Synced Jul 24, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01396421 live on ClinicalTrials.gov.

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