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TerminatedNCT00366704Updated Feb 11, 2013

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

A Phase 3 interventional study of bifeprunox and risperidone in Schizophrenia, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Terminated at 66 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-02-11.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 400 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    A

    Drug: bifeprunox

  • Active comparator
    B

    Drug: risperidone

Interventions

  • Drugbifeprunox

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

  • Drugrisperidone

    4mg, QD, 8 week treatment

06

What researchers measure

Primary outcomes

  1. The primary analysis will be the change from baseline on body weight at the final evaluation.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

07

Study locations

66 sites
  • Little Rock, Arkansas 72201, United States
  • Little Rock, Arkansas 72211, United States
  • Anaheim, California 92802, United States
  • Anaheim, California 92804, United States
  • Anaheim, California 92805, United States
  • Boynton Beach, California 33426, United States
  • Costa Mesa, California 92363, United States
  • Costa Mesa, California 92627, United States
  • Escondido, California 92025, United States
  • Garden Grove, California 92845, United States
  • Glendale, California 91206, United States
  • Huntington Beach, California 92648, United States
  • La Mesa, California 91942, United States
  • National City, California 91950, United States
  • Oceanside, California 92056, United States
  • Paramount, California 90723, United States
  • Rosemead, California 91770, United States
  • San Diego, California 92108, United States
  • San Diego, California 92123, United States
  • San Diego, California 92126, United States
  • Santa Ana, California 92701, United States
  • Santa Ana, California 92705, United States
  • New London, Connecticut 06320, United States
  • Ft. Lauderdale, Florida 33319, United States
  • Jacksonville, Florida 32256, United States
  • North Miami, Florida 33161, United States
  • St. Petersburg, Florida 33711, United States
  • Atlanta, Georgia 30307, United States
  • Atlanta, Georgia 30308, United States
  • Augusta, Georgia 30912, United States
  • Marietta, Georgia 30060, United States
  • Coevr d'Alene, Idaho 83814, United States
  • Chicago, Illinois 60631, United States
  • Hoffman Estates, Illinois 60194, United States
  • Joliet, Illinois 60077, United States
  • Naperville, Illinois 60540, United States
  • Lake Charles, Louisiana 70601, United States
  • Gaithersburg, Maryland 20877, United States
  • Pittsfield, Massachusetts 01201, United States
  • Worcester, Massachusetts 01605, United States
  • Flowood, Mississippi 39232, United States
  • St. Louis, Missouri 63110, United States
  • St. Louis, Missouri 63118, United States
  • St. Louis, Missouri 63128, United States
  • North Platte, Nebraska 69101, United States
  • Cherry Hill, New Jersey 08002, United States
  • Clementon, New Jersey 08021, United States
  • Rochester, New York 14624, United States
  • Staten Island, New York 10312, United States
  • Butner, North Carolina 27509, United States
  • Morehead City, North Carolina 28557, United States
  • Beachwood, Ohio 44122, United States
  • Cleveland, Ohio 44109, United States
  • Oklahoma City, Oklahoma 73139, United States
  • East Stroudsberg, Pennsylvania 18301, United States
  • Jenkintown, Pennsylvania 19046, United States
  • Norristown, Pennsylvania 19401, United States
  • Philadelphia, Pennsylvania 19149, United States
  • Pittsburgh, Pennsylvania 15108, United States
  • Cordova, Tennessee 38018, United States
  • Memphis, Tennessee 38105, United States
  • Memphis, Tennessee 38157, United States
  • Austin, Texas 78756, United States
  • DeSoto, Texas 75115, United States
  • Irving, Texas 75062, United States
  • San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00366704
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Solvay Pharmaceuticals
First posted
Aug 21, 2006
Start date
Nov 2006
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Feb 11, 2013

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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