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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00288574 |
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 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Fluoxetine After Weight Restoration in Anorexia Nervosa |
Estimated Enrollment: | 80 |
Study Start Date: | January 2000 |
Estimated Study Completion Date: | May 2005 |
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.
Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
New York State Psychiatric Institute/Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | B. Timothy Walsh, MD | New York State Psychiatric Institute/Columbia University Medical Center |
Principal Investigator: | Allan Kaplan, MD | Toronto General Hospital |
Study ID Numbers: | R01 MH60271, R01 MH60336, DSIR AT-P |
Study First Received: | February 6, 2006 |
Last Updated: | June 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00288574 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Depression |
Neurotransmitter Agents Depression Signs and Symptoms, Digestive Psychotropic Drugs Depressive Disorder Serotonin Uptake Inhibitors Serotonin Body Weight |
Fluoxetine Signs and Symptoms Mental Disorders Anorexia Anorexia Nervosa Antidepressive Agents, Second-Generation Antidepressive Agents Eating Disorders |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Fluoxetine Signs and Symptoms |
Serotonin Agents Mental Disorders Therapeutic Uses Anorexia Anorexia Nervosa Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents Eating Disorders |