Status:
TERMINATED
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Current treatment of at least 3 months with risperidone.
- Primary diagnosis of schizophrenia.
- Total Positive and Negative Symptoms Scale (PANSS) score \< or = 70 at screening and baseline.
- Exclusion criteria:
- Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis.
- History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
- History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00366704
Start Date
November 1 2006
End Date
March 1 2008
Last Update
February 11 2013
Active Locations (66)
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1
Little Rock, Arkansas, United States, 72201
2
Little Rock, Arkansas, United States, 72211
3
Anaheim, California, United States, 92802
4
Anaheim, California, United States, 92804