Official Title: “PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa”

Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. They will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia with healthy control women who have never had an eating disorder in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.

Study Type: Interventional

Study Design: Basic Science, Open Label, Parallel Assignment

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
  • 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Recovered anorexia

Primary Measures

• serotonin level
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• Recovered from Anorexia Nervosa
• Not taking medication for emotional problems
• Regular menstrual cycle

Exclusion Criteria:

• Women who are pregnant or nursing
• Psychoactive medications in the past 30 days
• Neurological disorders.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Walter Kaye, M.D. Principal Investigator UPMC  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603018

Study ID Number: PRO06110005

ClinicalTrials.gov Identifier: NCT00603018

Health Authority: United States: Institutional Review Board