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.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00044187
First received: August 21, 2002
Last updated: July 18, 2006
Last verified: July 2006

August 21, 2002
July 18, 2006
April 2001
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Complete list of historical versions of study NCT00044187 on ClinicalTrials.gov Archive Site
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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
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

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
  • Bipolar Disorder
Drug: Sibutramine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
September 2003
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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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044187
5102, F1D-MC-HGJJ
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Eli Lilly and Company
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Eli Lilly and Company
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP