Overview

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.