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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Fluoxetine

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)