Clinical Trial: Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Olanzapine vs Placebo for Outpatients With Anorexia Nervosa

Brief Summary: Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and mortality. Weight restoration is a treatment priority, and better treatments are needed.

Detailed Summary:

This study is a 16-week randomized, double-blind, placebo-controlled trial of olanzapine in adult outpatients with AN. 160 individuals with AN, ages > 18, will be randomly assigned to receive olanzapine or placebo for 16 weeks together with a medication management treatment. Primary outcomes will include weight gain as well as psychological symptoms known to be associated with AN, including obsessionality, mood, and anxiety.

This project is based on evidence from a recently completed 8-week pilot study comparing the efficacy of olanzapine to placebo in outpatients with AN (PI: Evelyn Attia, MD), as well as a recently published 12-week trial of olanzapine vs placebo (Bissada et al, Am J Psychiatry, 2007) in which outpatient treatment with olanzapine was associated with weight improvement, improved psychological status, and no untoward metabolic effects among low-weight patients.

The investigators hypothesize that among underweight adult outpatients with AN receiving olanzapine vs. placebo, together with medication management treatment: 1)patients with AN receiving olanzapine will gain weight at a faster rate than those receiving placebo; and 2) patients with AN receiving olanzapine will demonstrate greater reduction in psychological symptoms, including obsessionality, mood, anxiety and eating disorder symptoms, than those receiving placebo.


Sponsor: New York State Psychiatric Institute

Current Primary Outcome:

  • Rate of Weight Gain [ Time Frame: Weekly during 16-week trial and twice during 8 weeks follow-up ]
    Comparison of rate of weight gain between patients receiving olanzapine and those receiving placebo
  • Psychological Improvement [ Time Frame: Weekly during 16-week intervention and twice during 8-week follow-up ]
    Comparison of psychological improvement, specifically obsessionality as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: New York State Psychiatric Institute

Dates:
Date Received: July 23, 2010
Date Started: August 2010
Date Completion: June 2017
Last Updated: September 22, 2016
Last Verified: September 2016