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A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

This study has been completed.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd. Identifier:
First received: October 11, 2011
Last updated: October 5, 2016
Last verified: October 2016
To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Condition Intervention Phase
Drug: OPC-34712
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale(PANSS) Total Score from Baseline to Week6 [ Time Frame: Baseline, Week 6 ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression - Severity of Illness (CGI-S) from Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]

Enrollment: 458
Study Start Date: October 2011
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose Drug: OPC-34712
orally administered once daily
Experimental: Mid dose Drug: OPC-34712
orally administered once daily
Experimental: Low dose Drug: OPC-34712
orally administered once daily
Placebo Comparator: Placebo Drug: Placebo
orally administered once daily


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
  • Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
  • Patients who are experiencing acute exacerbation of psychotic symptoms

Exclusion Criteria:

  • Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
  • Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
  • Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
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Please refer to this study by its identifier: NCT01451164

Kanto Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Study Director: kyoji Imaoka, Operating Officer Otsuka Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT01451164     History of Changes
Other Study ID Numbers: 331-10-002
JapicCTI-111631 ( Other Identifier: JAPIC )
Study First Received: October 11, 2011
Last Updated: October 5, 2016

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on May 25, 2017