Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia Nervosa; Eating Disorders
Intervention: Fluoxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
B. Timothy Walsh, MD, Principal Investigator, Affiliation: New York State Psychiatric Institute/Columbia University Medical Center
Allan Kaplan, MD, Principal Investigator, Affiliation: Toronto General Hospital
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.
Clinical Details
Official title: Fluoxetine After Weight Restoration in Anorexia Nervosa
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Rate of AN relapse over 12 months (measured at Month 12)
Secondary outcome: Reduction in psychopathology associated with AN (measured at Months 12, 15, 18, 21, and 24)
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Meets DSM-IV criteria for anorexia nervosa (except the requirement for amenorrhea)
- Successfully completed treatment at one of the study sites in an inpatient or
day-program setting immediately prior to study entry (BMI remained at least 19 kg/m2
for two weeks)
Exclusion Criteria:
- Currently taking any medications other than occasional lorazepam or zopiclone for
anxiety or sleep disturbance
- Previous serious adverse reactions to fluoxetine (e. g., allergy)
- Currently at risk for suicide
- Any medical condition requiring treatment with other psychotropic medication (except
the occasional use of anti-anxiety medication)
- Pregnant
- Any serious medical illness besides the eating disorder
- History of continuous illness (at a low weight with no periods of remission or return
to normal functioning for more than 15 years)
Locations and Contacts
New York State Psychiatric Institute/Columbia University Medical Center, New York, New York 10032, United States
Additional Information
Starting date: January 2000
Ending date: May 2005
Last updated: June 23, 2006
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