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 - Tabular View

Tracking Information
First Received Date ^ICMJE	August 21, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE	April 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00044187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Schizophrenia Psychotic Disorders Bipolar Disorder
Intervention ^ICMJE	Drug: Sibutramine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	130
Completion Date	September 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00044187
Responsible Party
Study ID Numbers ^ICMJE	5102, F1D-MC-HGJJ
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP