Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Twice Daily Titration Study of the Safety and Tolerability of Bifeprunox in Subjects With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139906
• Other study ID #: S154.2.016
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: January 15, 2015
• Start date: August 2005
• Est. completion date: October 2006

Study information

• Verified date: March 2006
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Bifeprunox

Locations

Country	Name	City	State
United States	Site 1	National City	California

Sponsors (3)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals	H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States,