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

Condition(s) targeted: Schizophrenia

Intervention: bifeprunox, olanzapine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth Research

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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.

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia.

Study design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Primary outcome: Change from baseline on body weight at the final evaluation.

Secondary outcome: 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.

Detailed 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 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 Manager, Email: clintrialparticipation@wyeth.com

Little Rock, Arkansas 72201, United States; Recruiting

Little Rock, Arkansas 72211, United States; Recruiting

Escondido, California 92025, United States; Recruiting

National City, California 91950, United States; Recruiting

Santa Ana, California 92705, United States; Recruiting

Glendale, California 91206, United States; Recruiting

Oceanside, California 92056, United States; Terminated

Oceanside, California 92056, United States; Recruiting

San Diego, California 92108, United States; Recruiting

Anaheim, California 92805, United States; Recruiting

Boynton Beach, California 33426, United States; Recruiting

La Mesa, California 91942, United States; Recruiting

San Diego, California 92123, United States; Recruiting

Huntington Beach, California 92648, United States; Recruiting

San Diego, California 92126, United States; Recruiting

Paramount, California 90723, United States; Recruiting

Garden Grove, California 92845, United States; Recruiting

Anaheim, California 92802, United States; Recruiting

Anaheim, California 92804, United States; Recruiting

Rosemead, California 91770, United States; Recruiting

Costa Mesa, California 92627, United States; Not yet recruiting

Costa Mesa, California 92363, United States; Not yet recruiting

New Britain, Connecticut 06050, United States; Not yet recruiting

New London, Connecticut 06320, United States; Recruiting

Deland, Florida 32720, United States; Not yet recruiting

St. Petersburg, Florida 33711, United States; Recruiting

Ft. Lauderdale, Florida 33319, United States; Recruiting

North Miami, Florida 33161, United States; Recruiting

Jacksonville, Florida 32256, United States; Not yet recruiting

Marietta, Georgia 30060, United States; Recruiting

Augusta, Georgia 30912, United States; Recruiting

Atlanta, Georgia 30308, United States; Recruiting

Coevr d'Alene, Idaho 83814, United States; Recruiting

Naperville, Illinois 60540, United States; Recruiting

Hoffman Estates, Illinois 60194, United States; Recruiting

Chicago, Illinois 60631, United States; Recruiting

Joliet, Illinois 60077, United States; Not yet recruiting

Lake Charles, Louisiana 70601, United States; Not yet recruiting

Gaithersburg, Maryland 20877, United States; Not yet recruiting

Worcester, Massachusetts 01605, United States; Recruiting

Flowood, Mississippi 39232, United States; Not yet recruiting

St. Louis, Missouri 63128, United States; Recruiting

St. Louis, Missouri 63110, United States; Recruiting

St. Louis, Missouri 63118, United States; Not yet recruiting

North Platte, Nebraska 69101, United States; Recruiting

Clementon, New Jersey 08021, United States; Recruiting

Cherry Hill, New Jersey 08002, United States; Recruiting

New York, New York 10035, United States; Not yet recruiting

Rochester, New York 14624, United States; Recruiting

Staten Island, New York 10312, United States; Not yet recruiting

Durham, North Carolina 27707, United States; Recruiting

Chapel Hill, North Carolina 27599, United States; Terminated

Morehead City, North Carolina 28557, United States; Recruiting

Butner, North Carolina 27509, United States; Recruiting

Fargo, North Dakota 58102, United States; Not yet recruiting

Cleveland, Ohio 44109, United States; Recruiting

Oklahoma City, Oklahoma 73118, United States; Terminated

Oklahoma City, Oklahoma 73139, United States; Recruiting

Philadelphia, Pennsylvania 19149, United States; Recruiting

Pittsburgh, Pennsylvania 15108, United States; Not yet recruiting

Norristown, Pennsylvania 19401, United States; Not yet recruiting

Memphis, Tennessee 38105, United States; Recruiting

Nashville, Tennessee 37212, United States; Not yet recruiting

Cordova, Tennessee 38018, United States; Recruiting

Murfressboro, Tennessee 37129, United States; Terminated

Austin, Texas 78756, United States; Recruiting

DeSoto, Texas 75115, United States; Recruiting

Irving, Texas 75062, United States; Recruiting

Starting date: July 2006
Ending date: October 2006
Last updated: March 19, 2007