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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 Sep 2, 2026, 4:25 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, 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
Jul 31, 2009
Primary completion
Jul 31, 2011
Completion
Aug 31, 2011
Last update posted
Oct 28, 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 28, 2015 · Synced Sep 2, 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 protocol, eligibility criteria, and contact information for NCT01649557 live on ClinicalTrials.gov.

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