A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Phase 2

Conditions

Schizophrenia

Treatments

Drug: MP-214

Drug: Risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01625897

A002-A7

Details and patient eligibility

About

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.

Enrollment

125 patients

Sex

All

Ages

20 to 74 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 who meet at least one of the following:
- current diagnosis of schizophrenia of chronic phase
- between 65 and 74 years of age
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.