Conditions: Metabolic Complications
Keywords: Olanzapine Zyprexa Weight Gain Antipsychotics Metformin Glucophage Bipolar Disorder Schizophrenia Depression Diabetes Side effects Metabolic complications Prevention Treatment Metabolic side effects of olanzapine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

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 plus placebo.

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 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.

Arms:
arm 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. arm 2: Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.

Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Drug: Placebo. Subjects will remain on placebo for 6 months.

Protocol document: