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

NCT00366704 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-02-11

No results posted yet for this study

Summary

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

Conditions

  • Schizophrenia

Interventions

DRUG

bifeprunox

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

DRUG

risperidone

4mg, QD, 8 week treatment

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    collaborator INDUSTRY
  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00366704 on ClinicalTrials.gov