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A Randomized Controlled Trial

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

JAMA. 2006;295:2605-2612.

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.

Trial Registration  clinicaltrials.gov Identifier: NCT00288574

Author Affiliations: New York State Psychiatric Institute/Columbia University Medical Center, New York, NY (Drs Walsh, Attia, Parides, Pike, and Devlin and Ms Roberto); and University of Toronto and Toronto General Hospital, Toronto, Ontario (Drs Kaplan, Olmsted, Carter, and Woodside and Ms Rockert).

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RELATED LETTERS

Fluoxetine for Treatment of Anorexia Nervosa
Michael Dettling, Carolin Opgen-Rhein, Arnim Quante, and Ion Anghelescu
JAMA. 2006;296(20):2439-2440.
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Fluoxetine for Treatment of Anorexia Nervosa—Reply
B. Timothy Walsh, Christina A. Roberto, Allan S. Kaplan, and Wendi Rockert
JAMA. 2006;296(20):2440.
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