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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00139919
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : January 16, 2015
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE August 31, 2005
Last Update Posted Date January 16, 2015
Study Start Date  ICMJE January 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00139919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
Intervention  ICMJE Drug: Bifeprunox
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139919
Other Study ID Numbers  ICMJE S154.2.017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Solvay Pharmaceuticals
Collaborators  ICMJE
  • H. Lundbeck A/S
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
PRS Account Solvay Pharmaceuticals
Verification Date November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP