PET Imaging Study of Recovered Anorexics

Study Overview
=================
Brief 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. The women who have recovered from anorexia 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 before and after medication 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.

Official Title
-----------------
PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa

Intervention / Treatment
-----------------
* Drug: Fluoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Annorexia nervosa<br>Participants recovered from anorexia nervosa before and after administration of fluoxetine | Drug: Fluoxetine<br>* 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.<br>* Other names: Prozac;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors | We used PET and [11C]WAY to assess 5-HT1A binding potential (BP) = [11C]WAY 100635 BP = Distribution Volume (DV)ROI-DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3 | Baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eating disorders, anorexia nervosa, anorexia, PET, brain imaging, serotonin, fMRI, Prozac, fluoxetine