A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
- Registration Number
- NCT01626885
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Written informed consent obtained from the patient before the initiation of any study-specific procedures
- Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
- Patients who receive 1 or more antipsychotic drugs
- Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
Exclusion Criteria
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MP-214 1.5-9 mg MP-214 -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events as a Measure of Safety and Tolerability Up to 60 weeks
- Secondary Outcome Measures
Name Time Method