Clinical trial NCT00288574: Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa
Official title: Fluoxetine After Weight Restoration in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anorexia Nervosa
Eating Disorders
Keywords: Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-02-08
Enrollment: 93
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Proportion of Patients Remaining in Study at 1 Year
timeFrame: 12 months
Secondary outcomes:
measure: Change in Weight Per Month During Treatment
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale.
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale.
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale.
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale.
timeFrame: 12 months
measure: Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS)
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute/Columbia University Medical Center
state: New York
Study officials:
affiliation: New York State Psychiatric Institute/Columbia University Medical Center
name: B. Timothy Walsh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital
name: Allan Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh BT, Kaplan AS, Attia E, Olmsted M, Parides M, Carter JC, Pike KM, Devlin MJ, Woodside B, Roberto CA, Rockert W. Fluoxetine after weight restoration in anorexia nervosa: a randomized controlled trial. JAMA. 2006 Jun 14;295(22):2605-12. doi: 10.1001/jama.295.22.2605.