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Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

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ClinicalTrials.gov Identifier: NCT00396214
Recruitment Status : Terminated (This trial discontinued on 2 May 2008 due to lack of enrolment)
First Posted : November 6, 2006
Last Update Posted : June 4, 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 November 3, 2006
First Posted Date  ICMJE November 6, 2006
Last Update Posted Date June 4, 2008
Study Start Date  ICMJE April 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Weight [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Change from baseline in Triglyceride [ Time Frame: 8 weeks ]
  • Detorioration (composite definition using PANSS total score and CGI-I) [ Time Frame: 26 weeks ]
  • Change from baseline in Weight, Triglyceride and Cardiovascular risk factors [ Time Frame: 52 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 Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
Official Title  ICMJE A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
Brief Summary The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Bifeprunox
    52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
  • Drug: Quetiapine
    Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
  • Drug: Bifeprunox
    52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Bifeprunox
  • Experimental: 2
    Intervention: Drug: Bifeprunox
  • Active Comparator: 3
    Intervention: Drug: Quetiapine
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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 30, 2008)
83
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Schizophrenia
  • 18-65 years
  • No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period

Exclusion Criteria:

  • Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
  • At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history
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,   Chile,   Czech Republic,   Estonia,   Finland,   Germany,   Hungary,   Latvia,   Lithuania,   Peru,   Slovakia,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00396214
Other Study ID Numbers  ICMJE S154.3.021
2006-004973-83
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