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

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: risperidone; Drug: bifeprunox

• Registration Number: NCT00366704
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Study Start: 2006-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-04
• Disposition First Submitted: 2013-02-07
• Disposition First Submitted QC: 2013-02-07
• Last Update Submitted: 2013-02-07
• Disposition First Posted: 2013-02-11
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	risperidone	-
A	bifeprunox	-

Primary Outcome Measures

Name	Time	Method
The primary analysis will be the change from baseline on body weight at the final evaluation.	8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.	8 weeks