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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Bifeprunox Drug: Quetiapine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
Study Start Date : April 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 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.
Experimental: 2 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.
Active Comparator: 3 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.



Primary Outcome Measures :
  1. Weight [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Triglyceride [ Time Frame: 8 weeks ]
  2. Detorioration (composite definition using PANSS total score and CGI-I) [ Time Frame: 26 weeks ]
  3. Change from baseline in Weight, Triglyceride and Cardiovascular risk factors [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396214


  Show 151 Study Locations
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

Responsible Party: Loretta Stallings, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00396214     History of Changes
Other Study ID Numbers: S154.3.021
2006-004973-83
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: May 2008

Keywords provided by Solvay Pharmaceuticals:
Schizophrenia
weight changes

Additional relevant MeSH terms:
Schizophrenia
Body Weight Changes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight
Signs and Symptoms
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs