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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.

Sponsored by: 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

MedlinePlus related topics:   Bipolar Disorder    Obesity    Psychotic Disorders    Schizophrenia   

Drug Information available for:   Olanzapine    Sibutramine    Sibutramine hydrochloride monohydrate   

U.S. FDA Resources

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

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
      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

Sponsors and Collaborators
Eli Lilly and Company
  More Information


Study ID Numbers:   5102, F1D-MC-HGJJ
First Received:   August 21, 2002
Last Updated:   July 18, 2006
ClinicalTrials.gov Identifier:   NCT00044187
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Anti-Obesity Agents
Pathologic Processes
Disease
Therapeutic Uses
Psychotropic Drugs
Appetite Depressants
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

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