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Clinical Trials/NCT00396214
NCT00396214TerminatedPhase 3

A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

Solvay Pharmaceuticals151 sites in 1 country83 target enrollmentStarted: April 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
83
Locations
151
Primary Endpoint
Weight
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Intervention: Bifeprunox (Drug)

2

Experimental

Intervention: Bifeprunox (Drug)

3

Active Comparator

Intervention: Quetiapine (Drug)

Outcomes

Primary Outcomes

Weight

Time Frame: 8 weeks

Secondary Outcomes

  • Change from baseline in Triglyceride(8 weeks)
  • Detorioration (composite definition using PANSS total score and CGI-I)(26 weeks)
  • Change from baseline in Weight, Triglyceride and Cardiovascular risk factors(52 weeks)

Investigators

Sponsor Class
Industry

Study Sites (151)

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