Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa
Condition: Anorexia Nervosa; Eating Disorders
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate
      of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of
      people who have been treated for AN.
    

Detailed description: 
      Anorexia nervosa (AN), a type of eating disorder, is a serious psychiatric illness that is
      characterized by an extreme loss of appetite. People with AN view themselves as overweight
      and cannot bring themselves to eat, even though most are dangerously thin. Signs of the
      disorder include unusual eating habits, such as avoiding food and meals, picking out a few
      foods and eating them in small quantities, or carefully weighing and portioning food. Some
      people with AN fully recover after a single episode, some have a fluctuating pattern of
      weight gain and relapse, and others experience a chronic course of illness over many years.
      Effective drugs to treat the disorder are lacking. In addition, most past research has
      examined the effect of medications during the initial phase of treatment, a time when AN
      patients may not respond to medication because of the acute effects of starvation. Fluoxetine
      is a selective serotonin reuptake inhibitor (SSRI) that is commonly used to treat depression.
      This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate
      of relapse of AN and enhancing the psychosocial and behavioral recovery of women who have
      already been treated for AN.

      Participants in this double-blind study will be recruited immediately following completion of
      a treatment program for AN, in which they maintained a body mass index (BMI) of at least 19
      kg/m2 for two weeks. Upon study entry, participants will be randomly assigned to receive
      either fluoxetine or placebo for 12 months. Participants will begin receiving medication one
      week prior to discharge from the hospital in which they received care for AN. Medication
      doses will be increased up to a target dose of 60 mg per day, and will not exceed 80 mg per
      day. Participants will receive 50 sessions of cognitive-behavioral therapy, lasting
      approximately 45 minutes each and occurring twice weekly for the first month following
      discharge from the hospital. After the first month, therapy sessions will occur once weekly
      until Month 9 and then every other week until Month 12. Participants will also report to the
      study site to meet with a psychiatrist once a week for the first month following discharge
      and then every other week for the remainder of the study. General medical status, evidence of
      AN relapse, medication dose, and side effects will be assessed at these visits. Upon
      completing treatment, follow-up telephone calls will occur at Months 15 and 21, and follow-up
      visits will be held at Months 18 and 24. Psychopathology associated with AN, including
      concern with weight and shape, depressive symptoms, anxiety, and obsessive behavior, will be
      assessed.
    

Intervention name(s): Fluoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression