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A Long-term Trial of OPC-34712 in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01456897
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: OPC-34712 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: OPC-34712 Drug: OPC-34712
orally administered once daily


Outcome Measures

Primary Outcome Measures :
  1. The frequency and severity of Adverse events [ Time Frame: From baseline to week 52 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
  • Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible

Exclusion Criteria:

  • Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456897


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: NCT01456897     History of Changes
Other Study ID Numbers: 331-10-003
JapicCTI-111632 ( Other Identifier: JAPIC )
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016

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