PET Imaging Study of Recovered Anorexics

Anorexia Nervosa Clinical Trial

Official title:

PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603018
• Other study ID #: PRO06110005
• Status: Completed
• Phase: N/A
• First received: October 16, 2007
• Last updated: January 13, 2016
• Start date: June 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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

Other:
• No drug
No drug/control group

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serotonin level		8 weeks	No

External Links

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