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Completed Phase 2 Interventional Results available

Multicenter, Open-label, Safety and Tolerability Study

ClinicalTrials.gov ID: NCT01649557

Public ClinicalTrials.gov record NCT01649557. 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 18, 2026, 2:06 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 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients With Schizophrenia

Brief summary

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

This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.

Study identification

NCT ID
NCT01649557
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
244 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 67 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
Aug 2009 (Type not available)
Primary completion
Aug 2011 (Actual)
Completion
Sep 2011 (Actual)
Last update posted
Oct 29, 2015

2009 – 2011

United States locations

U.S. sites
16
U.S. states
8
U.S. cities
15
Facility City State ZIP Site status
Otsuka Investigational Site Little Rock Arkansas 72211 —
Otsuka Investigational Site Escondido California 92025 —
Otsuka Investigational Site Garden Grove California 92845 —
Otsuka Investigational Site Long Beach California 90813 —
Otsuka Investigational Site Oceanside California 92056 —
Otsuka Investigational Site Pasadena California 91106 —
Otsuka Investigational Site San Diego California 92102 —
Otsuka Investigational Site San Diego California 92123 —
Otsuka Investigational Site Santa Ana California 92701 —
Otsuka Investigational Site Washington D.C. District of Columbia 20016 —
Otsuka Investigational Site Bradenton Florida 34208 —
Otsuka Investigational Site Maitland Florida 32751 —
Otsuka Investigational Site St Louis Missouri 63118 —
Otsuka Investigational Site Cedarhurst New York 11516 —
Otsuka Investigational Site Philadelphia Pennsylvania 19139 —
Otsuka Investigational Site Austin Texas 78731 —

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 52 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01649557, 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 29, 2015 · Synced Oct 18, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01649557 live on ClinicalTrials.gov.

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