Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Metformin to Prevent the Metabolic Complications of Olanzapine|
- Weight Gain and Insulin Resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Dislipidemia, OGTT, Hemoglobin A1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months.
Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.
Placebo Comparator: 2
Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.
Drug: Placebo. Subjects will remain on placebo for 6 months.
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 pose a therapeutic dilemma for patients who respond well to olanzapine. Metabolic complications negatively impact on morbidity and mortality, impair quality of life and increase illness relapse secondary to medication non-compliance. Thus far, no pharmacologic agent co-administered with olanzapine has proven effective at preventing these untoward effects. The present study proposes to examine the efficacy and safety of metformin to attenuate the metabolic side effects associated with olanzapine.
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Jeffrey T Rado, M.D.||Rush University Medical Center|