Back to resultsA Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MP-214
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Central Nervous System Agents
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MP-214 1.5-9 mg
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Full Information
NCT ID
NCT01626885
First Posted
June 19, 2012
Last Updated
April 8, 2021
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01626885
Brief Title
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
Official Title
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Central Nervous System Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MP-214 1.5-9 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MP-214
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame
Up to 60 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Kurayoshi
State/Province
Tottori
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
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