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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044187
• Other study ID #: 5102
• Secondary ID: F1D-MC-HGJJ
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2002
• Last updated: July 18, 2006
• Start date: April 2001
• Est. completion date: September 2003

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Weight Gain

Intervention

Drug:
• Sibutramine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,