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

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: August 21, 2002
Last updated: July 18, 2006
Last verified: July 2006

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
Psychotic Disorders
Bipolar Disorder
Drug: Sibutramine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment: 130
Study Start Date: April 2001
Estimated Study Completion Date: September 2003

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00044187

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
Indianapolis, Indiana, United States
Lafayette, 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
Johnson City, Tennessee, United States
Memphis, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Bellevue, Washington, United States
Sponsors and Collaborators
Eli Lilly and Company
  More Information Identifier: NCT00044187     History of Changes
Other Study ID Numbers: 5102  F1D-MC-HGJJ 
Study First Received: August 21, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
schizoaffective disorder
schizophreniform disorder
bipolar I disorder

Additional relevant MeSH terms:
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Weight Gain
Bipolar and Related Disorders
Body Weight
Body Weight Changes
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Signs and Symptoms
Anti-Obesity Agents processed this record on May 26, 2016