Metformin for the Prevention of the Metabolic Side-effects of Zyprexa

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 plus placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborator: Eli Lilly and Company
• Treatments: Metformin; Olanzapine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.