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
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychotic Disorders; Bipolar Disorder
Intervention: Sibutramine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Eligibility Criteria:
- You must be between the ages of 18 and 65. If you have reached your 66th birthday,
you will not be able to participate.
- You must have been diagnosed with schizophrenia, schizoaffective disorder,
schizophreniform disorder, or bipolar I disorder and be taking olanzapine.
- You must be able to visit the doctor's office as scheduled for the next 4 months.
Exclusion Criteria:
- 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.
Locations and Contacts
El Centro, California, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Lafayette, Indiana, United States
Indianapolis, Indiana, United States
Prairie Village, Kansas, United States
Milford, Massachusetts, United States
Clementon, New Jersey, United States
Beachwood, Ohio, United States
Memphis, Tennessee, United States
Johnson City, Tennessee, United States
Houston, Texas, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Additional Information
Starting date: April 2001
Ending date: September 2003
Last updated: July 18, 2006
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