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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01451164
First received: October 11, 2011
Last updated: October 5, 2016
Last verified: October 2016
  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:
  • Change in Positive and Negative Syndrome Scale(PANSS) Total Score from Baseline to Week6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression - Severity of Illness (CGI-S) from Baseline to Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451164

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

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: October 5, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016