This trial is active, not recruiting.

Condition schizophrenia
Treatment mp-214
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients who meet eligibility criteria will be administered a once daily oral low dose of MP-214 for four weeks, then flexible dose of MP-214

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 60 weeks

Eligibility Criteria

Male or female participants from 20 years up to 64 years old.

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

Additional Information

Official title A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Mitsubishi Tanabe Pharma Corporation.