Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

ClinicalTrials.gov ID: NCT01393613

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Official title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

Study identification

NCT ID: NCT01393613
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 674 participants

Conditions and interventions

Conditions

Acute Schizophrenia

Interventions

OPC-34712 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: Jul 2011 (Type not available)
Primary completion: Feb 2014 (Actual)
Completion: Feb 2014 (Actual)
Last update posted: Nov 26, 2015

2011 – 2014

United States locations

U.S. sites: 19
U.S. states: 10
U.S. cities: 18

Facility	City	State	ZIP	Site status
Not listed	Little Rock	Arkansas	72201	—
Not listed	Springdale	Arkansas	72764	—
Not listed	Escondido	California	92025	—
Not listed	Long Beach	California	90813	—
Not listed	Orange	California	92868	—
Not listed	Pico Rivera	California	90660	—
Not listed	San Diego	California	92102	—
Not listed	North Miami	Florida	33161	—
Not listed	North Miami	Florida	33162	—
Not listed	Overland Park	Kansas	66212	—
Not listed	Lake Charles	Louisiana	70629	—
Not listed	Shreveport	Louisiana	71104	—
Not listed	Flowood	Mississippi	39232	—
Not listed	St Louis	Missouri	63118	—
Not listed	Buffalo	New York	14215	—
Not listed	Memphis	Tennessee	38119	—
Not listed	Austin	Texas	78756	—
Not listed	Dallas	Texas	75243	—
Not listed	Houston	Texas	77007	—

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 41 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01393613, 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 Nov 26, 2015 · Synced Nov 14, 2026