NCT00682448

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

Metformin to Prevent the Metabolic Complications of Olanzapine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Complications

Interventions

Type	Name	Description
DRUG	Metformin	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.
DRUG	Placebo	Drug: Placebo. Subjects will remain on placebo for 6 months.

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-05-22
• Last updated: 2021-02-02
• Results posted: 2021-02-02

Locations

1 site across 1 country: United States