A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
1 other identifier
interventional
125
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started May 2012
Typical duration for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 19, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
April 13, 2021
CompletedJanuary 5, 2026
December 1, 2025
2.8 years
June 19, 2012
January 11, 2021
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Up to 60 weeks
Study Arms (2)
MP-214 1.5-9mg
EXPERIMENTALRisperidone 2-12mg
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Aizu-Wakamatsu, Fukushima, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2012
First Posted
June 22, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
January 5, 2026
Results First Posted
April 13, 2021
Record last verified: 2025-12