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

This study has been completed.
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00139919
First received: August 30, 2005
Last updated: November 30, 2007
Last verified: November 2007
History of Changes
  Purpose

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
Schizophrenia
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:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: January 2006
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139919

Locations
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
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00139919     History of Changes
Other Study ID Numbers: S154.2.017
Study First Received: August 30, 2005
Last Updated: November 30, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Decreasing Titration Study
Schizophrenia
Bipolar
Pharmacokinetic

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
 Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 19, 2013