A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
This trial is active, not recruiting.
|Phase||phase 2/phase 3|
|Sponsor||Mitsubishi Tanabe Pharma Corporation|
|Start date||May 2012|
|Trial size||40 participants|
|Trial identifier||NCT01626885, A002-A8|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 60 weeks
Male or female participants from 20 years up to 64 years old.
- 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)
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
|Official title||A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia|
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