The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder

Completed · Phase 4

Conditions studied: Schizophrenia, Psychotic Disorders, Bipolar Disorder

In brief

Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine. The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.

Key facts

Study ID

NCT00044187

Run by

Eli Lilly and Company

People needed

130

Starts

2001-04-01

Expected to finish

2003-09-01

Last updated by the study team

2006-07-19

Who can join

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

You may not qualify if…

• You have a history of an illness that would cause weight loss or gain in the near future.
• You have taken remoxipride within the past 6 months.
• You are allergic to olanzapine or Anti-obesity Agent.
• You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke.
• You have a serious medical illness, such as heart, liver, or kidney disease.
• You are pregnant or breast feeding.

Where it is running

• Study site — El Centro, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lafayette, Indiana, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Milford, Massachusetts, United States
• Study site — Clementon, New Jersey, United States
• Study site — Beachwood, Ohio, United States
• Study site — Johnson City, Tennessee, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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