Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

Phase 2

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia

• Registration Number: NCT00139906
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Status Verified: 2006-03
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder
• Body weight of 100-250 lbs
• Male or females
• 18-55 years of age

Exclusion Criteria

• Subjects who are acutely psychotic
• Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Site 1; 🇺🇸 National City, California, United States