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

This study has been completed.
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: August 30, 2005
Last updated: January 15, 2015
Last verified: November 2007

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.

Condition Intervention Phase
Schizoaffective Disorder
Bipolar Disorder
Drug: Bifeprunox
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: January 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00139919

United States, California
Site 1
Orange, California, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided Identifier: NCT00139919     History of Changes
Other Study ID Numbers: S154.2.017
Study First Received: August 30, 2005
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Decreasing Titration Study

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features processed this record on October 09, 2015