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

Phase 4

Completed

• Conditions: Schizophrenia; Psychotic Disorders; Bipolar Disorder

• Registration Number: NCT00044187
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2002-08-21
• Study First Submitted QC: 2002-08-22
• Study First Posted: 2002-08-23
• Study Completion: 2003-09
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL