Safety and Efficacy of MP-214 in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Risperidone

Criteria

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 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.