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Completed

NCT Number: NCT00603018

PET Imaging Study of Recovered Anorexics

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoxetine

Drug

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

Other names: Prozac

Primary outcomes

  1. Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors

    Time frame: Baseline and 8 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 28, 2008
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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