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

Stopped early · Phase 3

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT00366704

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

400

Starts

2006-11-01

Expected to finish

2008-03-01

Last updated by the study team

2013-02-11

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 risperidone.
• Primary diagnosis of schizophrenia.
• Total Positive and Negative Symptoms Scale (PANSS) score < or = 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 — Santa Ana, California, United States
• Study site — New London, Connecticut, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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