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

Solvay

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Bifeprunox; Drug: Quetiapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396214

S154.3.021

2006-004973-83

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Bifeprunox

Drug: Bifeprunox

2

Experimental group

Treatment:

Drug: Bifeprunox

Drug: Bifeprunox

3

Active Comparator group

Treatment:

Drug: Quetiapine