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PET Imaging Study of Recovered Anorexics

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa focused on measuring eating disorders, anorexia nervosa, anorexia, PET, brain imaging, serotonin, fMRI, Prozac, fluoxetine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Annorexia nervosa

Arm Description

Participants recovered from anorexia nervosa before and after administration of fluoxetine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 16, 2007
Last Updated
August 2, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00603018
Brief Title
PET Imaging Study of Recovered Anorexics
Official Title
PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
eating disorders, anorexia nervosa, anorexia, PET, brain imaging, serotonin, fMRI, Prozac, fluoxetine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Annorexia nervosa
Arm Type
Experimental
Arm Description
Participants recovered from anorexia nervosa before and after administration of fluoxetine
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
Primary Outcome Measure Information:
Title
Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors
Description
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
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Kaye, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/15992780?ordinalpos=40&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
Description
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PET Imaging Study of Recovered Anorexics

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