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

This study has been terminated.
(This trial discontinued on 2 May 2008 due to lack of enrolment)
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00396214
First received: November 3, 2006
Last updated: May 30, 2008
Last verified: May 2008

November 3, 2006
May 30, 2008
April 2007
January 2008   (final data collection date for primary outcome measure)
Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00396214 on ClinicalTrials.gov Archive Site
  • Change from baseline in Triglyceride [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Detorioration (composite definition using PANSS total score and CGI-I) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Weight, Triglyceride and Cardiovascular risk factors [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • Experimental: 1
    Intervention: Drug: Bifeprunox
  • Experimental: 2
    Intervention: Drug: Bifeprunox
  • Active Comparator: 3
    Intervention: Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
83
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Chile,   Peru,   Czech Republic,   Estonia,   Finland,   Germany,   Hungary,   Latvia,   Lithuania,   Slovakia,   South Africa
 
NCT00396214
S154.3.021, 2006-004973-83
No
Loretta Stallings, Solvay Pharmaceuticals
Solvay Pharmaceuticals
  • H. Lundbeck A/S
  • Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
May 2008

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