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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00044187 |
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.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia Psychotic Disorders Bipolar Disorder |
Drug: Sibutramine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Assessment of a Anti-Obesity Agent for the Treatment of Olanzapine-Associated Weight Gain in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder and Bipolar I Disorder |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
Exclusion Criteria:
United States, California | |
El Centro, California, United States | |
United States, Florida | |
Jacksonville, Florida, United States | |
Miami, Florida, United States | |
United States, Idaho | |
Boise, Idaho, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Indiana | |
Lafayette, Indiana, United States | |
Indianapolis, Indiana, United States | |
United States, Kansas | |
Prairie Village, Kansas, United States | |
United States, Massachusetts | |
Milford, Massachusetts, United States | |
United States, New Jersey | |
Clementon, New Jersey, United States | |
United States, Ohio | |
Beachwood, Ohio, United States | |
United States, Tennessee | |
Memphis, Tennessee, United States | |
Johnson City, Tennessee, United States | |
United States, Texas | |
Houston, Texas, United States | |
United States, Virginia | |
Richmond, Virginia, United States | |
United States, Washington | |
Bellevue, Washington, United States |
Study ID Numbers: | 5102, F1D-MC-HGJJ |
Study First Received: | August 21, 2002 |
Last Updated: | July 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00044187 |
Health Authority: | United States: Food and Drug Administration |
schizoaffective disorder schizophreniform disorder bipolar I disorder |
Obesity Bipolar Disorder Olanzapine Weight Gain Sibutramine Body Weight Schizophrenia |
Signs and Symptoms Affective Disorders, Psychotic Mental Disorders Mood Disorders Body Weight Changes Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses Psychotropic Drugs |
Appetite Depressants Central Nervous System Agents Antidepressive Agents Pharmacologic Actions |