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NCT01625897 Clinical Trial

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

Schizophrenia Clinical Trial

Official title:
A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01625897
Other study ID # A002-A7
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 2012
Est. completion date March 2015

Study information
Verified date April 2021
Source Mitsubishi Tanabe Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MP-214
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
• Risperidone
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events as a Measure of Safety and Tolerability Up to 60 weeks
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