Status:
COMPLETED
Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Metabolic Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
We hypothesize that metformin co-administered with olanzapine will be well tolerated and associated with significantly less insulin resistance, weight gain and dyslipidemia as compared to olanzapine p...
Detailed Description
Increased risk of metabolic complications with olanzapine therapy, relative to other antipsychotics, may lead clinicians to avoid its use, despite evidence of greater efficacy. These problems may also...
Eligibility Criteria
Inclusion
- Diagnosis of: Schizophrenia, Schizoaffective Disorder, Bipolar I or II or major depression with psychotic features who will be started on or who have just started taking Olanzapine (Zyprexa).
Exclusion
- Patients with either a history of diabetes mellitus or a baseline FBG\>126 or two random blood sugars of \> 200 or during a OGTT glucose level of \> 200 two hours after a glucose load of 50 grams. (All American Diabetes Association criteria for diabetes mellitus).
- Baseline liver function tests (SGOT, SGPT, AP) greater than 3X normal.
- Chronic alcoholism
- MDRD less than 60 ml/1.73 m2. Modification of Diet in Renal Disease (MDRD) Equation estimates the glomerular filtration rate as a measure of kidney function. This equation takes into account the plasma creatinine, age, race and gender, and is a more accurate estimation of glomerular filtration rate than serum creatinine alone.
- Patients with unstable medical problems, including cardiovascular instability or significant congestive heart failure (as determined by study investigators).
- Prolonged QTc greater than 430 ms on baseline EKG.
- History of lactic acidosis.
- History of hypoglycemia.
- Current treatment with metformin or other antidiabetic agents.
- Treatment with any antihyperlipidemic medication within 3 months of randomization.
- Treatment with olanzapine or clozapine within 3 months of randomization.
- Concurrent treatment with ziprasidone, risperidone, quetiapine or aripiprazole or any other neuroleptic medication.
- Concurrent use of OTC chromium, gymnema or cimetidine will be prohibited. Patient may discontinue these medications up to one day prior to randomization.
- Current treatment with corticosteroids.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00682448
Start Date
August 1 2007
End Date
August 1 2011
Last Update
February 2 2021
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612