DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Psychotic Disorders; Bipolar Disorder

Intervention: Sibutramine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

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.

Clinical Details

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

El Centro, California, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Lafayette, Indiana, United States

Prairie Village, Kansas, United States

Milford, Massachusetts, United States

Clementon, New Jersey, United States

Beachwood, Ohio, United States

Johnson City, Tennessee, United States

Memphis, Tennessee, United States

Houston, Texas, United States

Richmond, Virginia, United States

Bellevue, Washington, United States

Additional Information

Starting date: April 2001
Last updated: July 18, 2006

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017