Fluoxetine after weight restoration in anorexia nervosa: A randomized controlled trial

B. Timothy Walsh, Allan S. Kaplan, Evelyn Attia, Marion Olmsted, Michael Parides, Jacqueline C. Carter, Kathleen M. Pike, Michael J. Devlin, Blake Woodside, Christina A. Roberto, Wendi Rockert

Research output: Contribution to journalArticlepeer-review

325 Scopus citations


Context: Antidepressant medication is frequently prescribed for patients with anorexia nervosa. Objective: To determine whether fluoxetine can promote recovery and prolong time-to-relapse among patients with anorexia nervosa following weight restoration. Design, Setting, and Participants: Randomized, double-blind, placebo-controlled trial. From January 2000 until May 2005, 93 patients with anorexia nervosa received intensive inpatient or day-program treatment at the New York State Psychiatric Institute or Toronto General Hospital. Participants regained weight to a minimum body mass index (calculated as weight in kilograms divided by the square of height in meters) of 19.0 and were then eligible to participate in the randomized phase of the trial. Interventions: Participants were randomly assigned to receive fluoxetine or placebo and were treated for up to 1 year as outpatients in double-blind fashion. All patients also received individual cognitive behavioral therapy. Main Outcome Measures: The primary outcome measures were time-to-relapse and the proportion of patients successfully completing 1 year of treatment. Results: Forty-nine patients were assigned to fluoxetine and 44 to placebo. Similar percentages of patients assigned to fluoxetine and to placebo maintained a body mass index of at least 18.5 and remained in the study for 52 weeks (fluoxetine, 26.5%; placebo, 31.5%; P = .57). In a Cox proportional hazards analysis, with prerandomization body mass index, site, and diagnostic subtype as covariates, there was no significant difference between fluoxetine and placebo in time-to-relapse (hazard ratio, 1.12; 95% CI, 0.65-2.01; P = .64). Conclusions: This study failed to demonstrate any benefit from fluoxetine in the treatment of patients with anorexia nervosa following weight restoration. Future efforts should focus on developing new models to understand the persistence of this illness and on exploring new psychological and pharmacological treatment approaches.

Original languageEnglish (US)
Pages (from-to)2605-2612
Number of pages8
JournalJAMA - Journal of the American Medical Association
Issue number22
StatePublished - Jun 14 2006
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


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