Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

Wyeth

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: bifeprunox; Drug: risperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366704

B3101009 (Other Identifier)

3168A1-313

Details and patient eligibility

About

The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current treatment of at least 3 months with risperidone.
• Primary diagnosis of schizophrenia.
• Total Positive and Negative Symptoms Scale (PANSS) score < or = 70 at screening and baseline.

Exclusion criteria

• Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis.
• History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
• History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: bifeprunox

B

Active Comparator group

Treatment:

Drug: risperidone