NCT00396214

Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Bifeprunox	52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
DRUG	Quetiapine	Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
DRUG	Bifeprunox	52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-11-06
• Last updated: 2008-06-04

Locations

151 sites across 14 countries: United States, Argentina, Canada, Chile, Czechia, Estonia, Finland, Germany, Hungary, Latvia, Lithuania, Peru, Slovakia, South Africa