Fluoxetine After Weight Restoration in Anorexia Nervosa: A Randomized Controlled Trial

University of Toronto, Toronto, Ontario, Canada
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 07/2006; 295(22):2605-12. DOI: 10.1001/jama.295.22.2605
Source: PubMed


Antidepressant medication is frequently prescribed for patients with anorexia nervosa.
To determine whether fluoxetine can promote recovery and prolong time-to-relapse among patients with anorexia nervosa following weight restoration.
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.
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.
The primary outcome measures were time-to-relapse and the proportion of patients successfully completing 1 year of treatment.
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).
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. Identifier: NCT00288574.

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Available from: Kathleen M Pike, Sep 29, 2015
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    • "Three small trials were identified utilising CBT as a relapse prevention strategy with post-hospitalised, weight restored AN participants, showing positive preliminary results [95-97]. SSRIs were also investigated in another two trials using similar weight restored samples, however no effects above placebo were noted [98,99]. Of concern is that large proportions of intervention arm participants across these trials still experienced relapse. "
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    ABSTRACT: Eating disorders often develop during adolescence and young adulthood, and are associated with significant psychological and physical burden. Identifying evidence-based interventions is critical and there is need to take stock of the extant literature, to inform clinical practice regarding well-researched interventions and to direct future research agendas by identifying gaps in the evidence base.
    International Journal of Eating Disorders 02/2014; 2(1):5. DOI:10.1186/2050-2974-2-5 · 3.13 Impact Factor
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    • "The items have been shown to have good internal consistency and test-retest reliability (ranging from .72 to .92) [26]. "
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    ABSTRACT: Background Engaging patients with an eating disorder in change is difficult and intensive treatment programs have high drop-out rates. The purpose of the study was to determine whether Motivational Interviewing (MI) in the form of a brief, pre-treatment intervention would be associated with higher completion rates in subsequent intensive treatment for an eating disorder. Thirty-two participants diagnosed with an eating disorder participated in the study. All participants were on the waitlist for admission to an intensive, hospital-based treatment program. Sixteen participants were randomly assigned to four individual sessions of MI that began prior to entrance into the treatment program (MI condition) and 16 participants were assigned to treatment as usual (control condition). The main outcome was completion of the intensive treatment program. Participants also completed self-report measures of motivation to change. Results Participants in the MI condition were significantly more likely to complete intensive treatment (69% completion rate) than were those in the control condition (31%). Conclusions MI can be a useful intervention to engage individuals with severe eating disorders prior to participation in intensive treatment. MI as a brief prelude to hospital-based treatment for an eating disorder may help to improve completion rates in such programs. Further research is required to determine the precise therapeutic mechanisms of change in MI.
    International Journal of Eating Disorders 08/2013; 1:34. DOI:10.1186/2050-2974-1-34 · 3.13 Impact Factor
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    • "There was no benefit from SSRIs in relapse prevention, core ED symptoms, depressive or obsessive-compulsive symptoms in a retrospective study of partially weight-restored female adolescents with AN [12]. Likewise, fluoxetine did not prevent relapse in weight-restored AN adults receiving cognitive-behavioural therapy [13]. The well-publicised finding of a small but significant increased risk of suicidality in youth after commencement of SSRIs was derived from meta-analyses of trials conducted for depression and anxiety disorders [14]; it is unknown to what extent these findings generalise to EDs. "
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    ABSTRACT: Background To describe the rates, indications, and adverse effects of psychotropic drug prescription in a specialist tertiary hospital child and adolescent eating disorder service. Methods Retrospective case note study of all active eating disorder patients (N = 115) over the period of treatment from referral to time of study (M = 2 years), covering patient demographics, clinical characteristics, drug prescriptions, indications, and adverse effects. Results Psychotropic drugs were prescribed in 45% of cases, most commonly antidepressants (41%), followed by anxiolytics (29%) and antipsychotics (22%), with 8% initiated before referral to the specialist eating disorder program. Common indications were depressed mood, agitation, anxiety, and insomnia. Patient clinical severity and complexity was associated with prescribing. Adverse effects, mostly minor, were recorded in 23% of antidepressant prescriptions, 39% of antipsychotic prescriptions, and 13% of anxiolytic prescriptions. Second generation antipsychotic prescription was associated with subsequent new onset binge eating, in this preliminary observational study. Self-harm by overdose of psychotropics occurred in 11% of patients prescribed medication. Conclusions Psychotropic medications were frequently prescribed to adolescent eating disorder patients to treat distressing symptoms. Prospective randomised controlled trials to clarify efficacy and safety are needed. Given the difficulties of conducting clinical trials in this population, services are encouraged to monitor and audit medication safety and efficacy in everyday practice, and to report their findings.
    International Journal of Eating Disorders 08/2013; 1:27. DOI:10.1186/2050-2974-1-27 · 3.13 Impact Factor
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