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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01626885
First received: June 19, 2012
Last updated: January 22, 2015
Last verified: January 2015

June 19, 2012
January 22, 2015
May 2012
June 2014   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 60 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01626885 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: MP-214
Patients who meet eligibility criteria will be administered a once daily oral low dose of MP-214 for four weeks, then flexible dose of MP-214
Experimental: MP-214
Intervention: Drug: MP-214
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01626885
A002-A8
Not Provided
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP