Fluoxetine after weight restoration in anorexia nervosa: a randomized controlled trial.
BACKGROUND
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.


METHODS
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.


METHODS
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.


METHODS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00288574.
Walsh
B Timothy
BT
New York State Psychiatric Institute/Columbia University Medical Center, New York, NY 10032, USA. btw1@columbia.edu
Kaplan
Allan S
AS
Attia
Evelyn
E
Olmsted
Marion
M
Parides
Michael
M
Carter
Jacqueline C
JC
Pike
Kathleen M
KM
Devlin
Michael J
MJ
Woodside
Blake
B
Roberto
Christina A
CA
Rockert
Wendi
W
D000293:Adolescent; D000328:Adult; D000856:Anorexia Nervosa / Q000188:drug therapy*; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D015992:Body Mass Index; D015928:Cognitive Behavioral Therapy; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D015430:Weight Gain
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors