Status:
COMPLETED
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Schizophrenia
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 effective, tolerable, and safe as compared wi...
Eligibility Criteria
Inclusion
- Provide written informed consent and aged between 18 and 75 years of age.
- Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
- Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Exclusion
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Any chronic organic disease of the CNS (other than schizophrenia).
- Used investigational compound within 30 days.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT00790192
Start Date
October 1 2008
End Date
July 1 2010
Last Update
March 17 2016
Active Locations (65)
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1
K&S Professional Research Services, LLC
Little Rock, Arkansas, United States, 72201
2
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
3
Clinical Pharmacological Studies, Inc.
Cerritos, California, United States, 90703
4
Comprehensive Neuroscience, Inc
Cerritos, California, United States, 90703