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

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00380224

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

120

Starts

2006-07-01

Expected to finish

2007-09-01

Last updated by the study team

2007-12-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Anaheim, California, United States
• Study site — Anaheim, California, United States
• Study site — Boynton Beach, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Escondido, California, United States
• Study site — Garden Grove, California, United States
• Study site — Glendale, California, United States
• Study site — Huntington Beach, California, United States
• Study site — La Mesa, California, United States
• Study site — National City, California, United States
• Study site — Oceanside, California, United States
• Study site — Paramount, California, United States
• Study site — Rosemead, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — New Britain, Connecticut, United States
• Study site — New London, Connecticut, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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