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

This study is currently recruiting participants.
Verified May 2013 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01451164
First received: October 11, 2011
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Positive and Negative Syndrome Scale(PANSS) Total Score [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Severity of Illness (CGI-S) [ Designated as safety issue: No ]

Study Start Date: October 2011
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451164

Contacts
Contact: Drug Information Center opc_ctr@otsuka.jp

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

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01451164     History of Changes
Other Study ID Numbers: 331-10-002, JapicCTI-111631
Study First Received: October 11, 2011
Last Updated: May 15, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014