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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:
ClinicalTrials.gov Identifier:
NCT00396214
First Posted: November 6, 2006
Last Update Posted: June 4, 2008
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.
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
  Purpose
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 Intervention Phase
Schizophrenia Drug: Bifeprunox Drug: Quetiapine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Weight [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 83
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Loretta Stallings, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00396214     History of Changes
Other Study ID Numbers: S154.3.021
2006-004973-83
First Submitted: November 3, 2006
First Posted: November 6, 2006
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