Status:
COMPLETED
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically...
Eligibility Criteria
Inclusion
- Main
- To be eligible to enter the study, each patient must comply with the following inclusion criteria:
- Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
- Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
- Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
- Subject voluntarily agrees to participate in the study by giving written informed consent.
- Main
Exclusion
- To be excluded from entering this study if they fulfil any of the criteria below:
- Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
- Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
- In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
- Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT00641745
Start Date
March 1 2008
End Date
July 1 2010
Last Update
June 22 2015
Active Locations (73)
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1
K&S Professional Research Services LLC
Little Rock, Arkansas, United States, 72201
2
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
3
South Coast Clinical Trials, Inc.
Anaheim, California, United States, 92804
4
Comprehensive NeuroScience, Inc. - Cerritos
Cerritos, California, United States, 90703