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Trial record 1 of 1 for:    NCT00347425
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Switch Study of Existing Atypical Antipsychotics to Bifeprunox

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: NCT00347425
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 21, 2008
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 June 30, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date May 21, 2008
Study Start Date  ICMJE December 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Adverse events [ Time Frame: 4 weeks ]
  • Adverse events [ Time Frame: 26 weeks ]
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 Switch Study of Existing Atypical Antipsychotics to Bifeprunox
Official Title  ICMJE A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder
Brief Summary The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia and Schizoaffective Disorder
Intervention  ICMJE
  • Drug: Aripiprazole
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Olanzapine
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Risperidone
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Quetiapine
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Ziprasidone
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Aripiprazole
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Olanzapine
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Risperidone
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Quetiapine
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Ziprasidone
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Study Arms  ICMJE
  • A
    Interventions:
    • Drug: Aripiprazole
    • Drug: Olanzapine
    • Drug: Risperidone
    • Drug: Quetiapine
    • Drug: Ziprasidone
  • B
    Interventions:
    • Drug: Aripiprazole
    • Drug: Olanzapine
    • Drug: Risperidone
    • Drug: Quetiapine
    • Drug: Ziprasidone
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
Actual Enrollment  ICMJE
 (submitted: March 20, 2008)
286
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated

Exclusion Criteria:

  • Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Czech Republic,   Estonia,   France,   Hungary,   Latvia,   Lithuania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347425
Other Study ID Numbers  ICMJE S154.3.020
2006-004972-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Loretta Stallings, Solvay Pharmaceuticals
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 May 2008

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