Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborator: Solvay Pharmaceuticals
• Treatments: Risperidone

Criteria

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.