Safety and Efficacy of MP-214 in Patients With Schizophrenia

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophrenia

Treatments: Drug: MP-214 9mg; Drug: MP-214 3mg; Drug: MP-214 6mg; Drug: Placebo; Drug: Risperidone 4mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01625000

A002-A4

Details and patient eligibility

About

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.

Enrollment: 512 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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512 participants in 5 patient groups, including a placebo group

MP-214 3mg

Experimental group

Treatment:

Drug: MP-214 3mg

MP-214 6mg

Experimental group

Treatment:

Drug: MP-214 6mg

MP-214 9mg

Experimental group

Treatment:

Drug: MP-214 9mg

Risperidone 4mg

Active Comparator group

Treatment:

Drug: Risperidone 4mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo