A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
- Registration Number
- NCT01625897
- 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 chronic phase or elderly schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
-
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 meet at least one of the following:
- current diagnosis of schizophrenia of chronic phase
- between 65 and 74 years of age
-
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Risperidone 2-12mg Risperidone - MP-214 1.5-9mg 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