PET Imaging Study of Recovered Anorexics

NCT00603018 | Completed Results DMC

• 1 other identifier: PRO06110005
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

eating disorders; anorexia nervosa; anorexia; PET; brain imaging; serotonin; fMRI; Prozac; fluoxetine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Annorexia nervosa

EXPERIMENTAL

Participants recovered from anorexia nervosa before and after administration of fluoxetine

Drug: Fluoxetine

Interventions

Fluoxetine DRUG

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

Also known as: Prozac

Annorexia nervosa

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recovered from Anorexia Nervosa
• Not taking medication for emotional problems
• Regular menstrual cycle

You may not qualify if:

• Women who are pregnant or nursing
• Psychoactive medications in the past 30 days
• Neurological disorders.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders; Anorexia

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Walter Kaye, MD/Director, Eating Disorders Program Professor, UCSD Department of Psychiatry
• Organization: UCSD

wkaye@ucsd.edu

858- 534-8019

Study Officials

• Walter Kaye, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/Director, Eating Disorders Program Professor,

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: January 28, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 23, 2016
• Results First Posted: September 23, 2016

Record last verified: 2016-08

Locations

US (1)