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.

First Received on August 21, 2002. Last Updated on July 18, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00044187

Purpose

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:	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:

MedlinePlus related topics: Bipolar Disorder Mental Disorders Obesity Psychotic Disorders Schizophrenia

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

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

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044187

Locations

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

No publications provided

ClinicalTrials.gov 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
Obesity
Psychotic Disorders
Mental Disorders
Schizophrenia
Weight Gain
Affective Disorders, Psychotic
Mood Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Body Weight Changes

Sibutramine
Anti-Obesity Agents
Olanzapine
Appetite Depressants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012