A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

Tanabe Pharma Corporation42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

MP-214DRUG

Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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 The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Unnamed facility

Kurayoshi, Tottori, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame: Up to 60 weeks

Data from ClinicalTrials.gov

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