Status:
COMPLETED
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Schizophrenia
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be admini...
Eligibility Criteria
Inclusion
- Patients meeting DSM-IV-TR criteria for schizophrenia
- PANSS total score \<= 120 during the observation period
- Patients who have been treated with oral antipsychotics within 4 weeks before informed consent
- Patients whose consent is obtained from themselves in written form
Exclusion
- Patients who have defined as any mental disorder other than "Schizophrenia" based on the criteria of DSM-IV-TR
- History of drug or alcohol abuse
- Concurrent Parkinson's disease
- History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
- Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values
- Current cataract during the observation period
- History of shock or anaphylactoid symptoms to drugs
- The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00862992
Start Date
April 1 2008
End Date
September 1 2009
Last Update
January 5 2026
Active Locations (1)
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1
Hoyu Hospital
Kure, Hiroshima, Japan