Status:
COMPLETED
Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
Lead Sponsor:
Eli Lilly and Company
Conditions:
Schizophrenia
Schizoaffective Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The goal of this study is to answer the following questions: * Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine * W...
Eligibility Criteria
Inclusion
- You must have been diagnosed with schizophrenia or schizoaffective disorder
- You must be able to visit the doctor's office once every two weeks for three months, then once every four weeks for the next three months with a possible bi-weekly visit during the fifth month
- If you are currently taking a medication for schizophrenia or schizoaffective disorder, you have been taking it for at least 30 days without any changes
- If you are a female, you must have a negative pregnancy test and be using an effective method of contraception
Exclusion
- You have a diagnosis of bipolar I disorder, diabetes, very high triglyceride level (fasting triglycerides greater than or equal to 500 mg/dL), recent heart attack, stroke, uncontrolled seizures, serious infection, unstable heart disease (such as ischemic heart disease or congestive heart failure), an uncorrected narrow angle glaucoma or human immunodeficiency virus (HIV)
- You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood
- You have a diagnosis of an eating disorder
- You have a history of Parkinson's Disease or any related disorders
- You are allergic to sulfa drugs or any of the medications involved in this study
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00401973
Start Date
November 1 2006
End Date
September 1 2008
Last Update
October 6 2009
Active Locations (15)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
National City, California, United States, 91950
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Canton, Ohio, United States, 44708
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Johnson City, Tennessee, United States, 37614
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, United States, 38105