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

A Multicenter, Randomized, Double-blind, Parallel-group Fixed-dose Study of the Effect on Weight of Bifeprunox Versus Risperidone in the Treatment of Outpatients With Schizophrenia.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366704

Enrollment

400

Registered

2006-08-21

Start date

2006-11-30

Completion date

2008-03-31

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia

Brief summary

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

Interventions

DRUGbifeprunox

.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)

DRUGrisperidone

4mg, QD, 8 week treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
The primary analysis will be the change from baseline on body weight at the final evaluation.	8 weeks

Secondary

Measure	Time frame
Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026