Status:
COMPLETED
Fluoxetine to Prevent Relapse and Enhance Psychological Recovery in Women With Anorexia Nervosa
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anorexia Nervosa
Eating Disorders
Eligibility:
FEMALE
16-45 years
Phase:
PHASE4
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 ha...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00288574
Start Date
January 1 2000
End Date
May 1 2005
Last Update
December 13 2017
Active Locations (1)
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1
New York State Psychiatric Institute/Columbia University Medical Center
New York, New York, United States, 10032