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

Completed · Phase 4 · Has a placebo group

Conditions studied: Metabolic Complications

In brief

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.

Key facts

Study ID

NCT00682448

Run by

Rush University Medical Center

People needed

25

Starts

2007-08-01

Expected to finish

2011-08-01

Last updated by the study team

2021-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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