Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00288574
First received: February 6, 2006
Last updated: May 26, 2016
Last verified: March 2015
  Purpose
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.

Condition Intervention Phase
Anorexia Nervosa
Eating Disorders
Drug: Fluoxetine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Fluoxetine After Weight Restoration in Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Proportion of Patients Remaining in Study at 1 Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining > 85% Ideal Body Weight.


Enrollment: 93
Study Start Date: January 2000
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluoxetine
fluoxetine up to 80 mg per day
Drug: Fluoxetine
Placebo Comparator: Placebo
Placebo
Drug: Placebo

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

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288574

Locations
United States, New York
New York State Psychiatric Institute/Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: B. Timothy Walsh, MD New York State Psychiatric Institute/Columbia University Medical Center
Principal Investigator: Allan Kaplan, MD Toronto General Hospital
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00288574     History of Changes
Other Study ID Numbers: #4703R  R01MH060271  R01MH060336  DSIR AT-P 
Study First Received: February 6, 2006
Results First Received: September 8, 2015
Last Updated: May 26, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Depression

Additional relevant MeSH terms:
Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2016