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...
Date First Received: October 16, 2007
Last Updated: May 21, 2008
Verified by: University of Pittsburgh, May 2008
Clinical Trial Phase: N/A | Start Date: June 2007
Overall Status: Recruiting
Estimated Enrollment: 120
Brief Summary
Official Title: “PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa”
Condition Keyword(s):
Intervention(s):
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: June 2017
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
Outcome Measures for this Clinical Trial
Primary Measures
- serotonin level
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: University of Pittsburgh
Overall Clinical Trial Officials and Contacts
Walter Kaye, M.D. Principal Investigator UPMC
Overall Contact: Sharon D Barnes, PhD 412-647-9964 barnessd@upmc.edu
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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
Clinical Trials Authorship and Review
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