A Long-term Trial of OPC-34712 in Patients With Schizophrenia
This study is currently recruiting participants.
Verified May 2013 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01456897
First received: October 11, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: OPC-34712 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- The frequency and severity of Adverse events [ Designated as safety issue: Yes ]
| Study Start Date: | October 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: OPC-34712 |
Drug: OPC-34712
orally administered once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456897
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: | NCT01456897 History of Changes |
| Other Study ID Numbers: | 331-10-003, JapicCTI-111632 |
| 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 May 22, 2013