Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study of the Safety and Tolerability of Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Either Schizophrenia or Bipolar Disorder With an Optional Open-Label 26-Week Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139919
• Other study ID #: S154.2.017
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: January 15, 2015
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2007
• 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 tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria

• Age 18 to 55

• Body weight 100-250 lbs

• Be sufficiently stable to allow discontinuation of antipsychotic medication

Exclusion Criteria:

• Acutely psychotic subjects

• Subjects that are acutely manic

• Subjects with a psych diagnosis other than Bipolar Type I Disorder

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Bifeprunox

Locations

Country	Name	City	State
United States	Site 1	Orange	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,