Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

Last updated: December 18, 2007
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Mood Disorders

Psychosis

Treatment

N/A

Clinical Study ID

NCT00380224
3168A1-311
  • Ages 18-65
  • All Genders

Study Summary

This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Current treatment of at least 3 months with olanzapine.

  • Primary diagnosis of schizophrenia.

  • Total Positive and Negative Symptoms Scale (PANSS) score <=70 at screening andbaseline.

Exclusion

Exclusion criteria:

  • Psychiatric diagnosis other than schizophrenia, as assessed by the modified MiniInternational Neuropsychiatric Interview (MINI), and considered by the investigator tobe 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 confoundthe study.

  • History of any suicide attempt within 3 years of day -1 or significant immediate riskof violence or suicidality.

Study Design

Total Participants: 120
Study Start date:
July 01, 2006
Estimated Completion Date:
September 30, 2007

Study Description

This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

Connect with a study center

  • Little Rock, Arkansas 72201
    United States

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  • Anaheim, California 92802
    United States

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  • Boynton Beach, California 33426
    United States

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  • Costa Mesa, California 92363
    United States

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  • Escondido, California 92025
    United States

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  • Garden Grove, California 92845
    United States

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  • Glendale, California 91206
    United States

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  • Huntington Beach, California 92648
    United States

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  • La Mesa, California 91942
    United States

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  • National City, California 91950
    United States

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  • Oceanside, California 92056
    United States

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  • Paramount, California 90723
    United States

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  • Rosemead, California 91770
    United States

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  • San Diego, California 92126
    United States

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  • Santa Ana, California 92705
    United States

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  • New Britain, Connecticut 06050
    United States

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  • New London, Connecticut 06320
    United States

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  • Deland, Florida 32720
    United States

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  • Ft. Lauderdale, Florida 33319
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  • Jacksonville, Florida 32256
    United States

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  • North Miami, Florida 33161
    United States

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  • St. Petersburg, Florida 33711
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  • Atlanta, Georgia 30308
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  • Augusta, Georgia 30912
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  • Marietta, Georgia 30060
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  • Coevr d'Alene, Idaho 83814
    United States

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  • Chicago, Illinois 60631
    United States

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  • Hoffman Estates, Illinois 60194
    United States

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  • Joliet, Illinois 60077
    United States

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  • Naperville, Illinois 60540
    United States

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  • Lake Charles, Louisiana 70601
    United States

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  • Gaithersburg, Maryland 20877
    United States

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  • Worcester, Massachusetts 01605
    United States

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  • Flowood, Mississippi 39232
    United States

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  • St. Louis, Missouri 63110
    United States

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  • North Platte, Nebraska 69101
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  • Cherry Hill, New Jersey 08002
    United States

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  • Clementon, New Jersey 08021
    United States

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  • New York, New York 10035
    United States

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  • Rochester, New York 14624
    United States

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  • Staten Island, New York 10312
    United States

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  • Butner, North Carolina 27509
    United States

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  • Chapel Hill, North Carolina 27599
    United States

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  • Durham, North Carolina 27707
    United States

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  • Morehead City, North Carolina 28557
    United States

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  • Fargo, North Dakota 58102
    United States

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  • Cleveland, Ohio 44109
    United States

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  • Oklahoma City, Oklahoma 73118
    United States

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  • Norristown, Pennsylvania 19401
    United States

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  • Philadelphia, Pennsylvania 19149
    United States

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  • Pittsburgh, Pennsylvania 15108
    United States

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  • Cordova, Tennessee 38018
    United States

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  • Memphis, Tennessee 38105
    United States

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  • Murfressboro, Tennessee 37129
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  • Nashville, Tennessee 37212
    United States

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  • Austin, Texas 78756
    United States

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  • DeSoto, Texas 75115
    United States

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  • Irving, Texas 75062
    United States

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