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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:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Loretta Stallings, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00396214     History of Changes
Other Study ID Numbers: S154.3.021, 2006-004973-83
Study First Received: November 3, 2006
Last Updated: May 30, 2008
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control

Keywords provided by Solvay Pharmaceuticals:
Schizophrenia
weight changes

Additional relevant MeSH terms:
Body Weight Changes
Schizophrenia
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013