PET Imaging Study of Recovered Anorexics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00603018
First received: October 16, 2007
Last updated: September 29, 2009
Last verified: October 2008
  Purpose

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.


Condition Intervention
Anorexia Nervosa
Drug: Fluoxetine

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • serotonin level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Recovered anorexia
Drug: Fluoxetine
8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
Other Name: Prozac

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603018

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Walter Kaye, M.D. University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Walter Kaye, MD, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00603018     History of Changes
Other Study ID Numbers: PRO06110005
Study First Received: October 16, 2007
Last Updated: September 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
eating disorders
anorexia nervosa
anorexia
PET
brain imaging
serotonin
fMRI
Prozac
fluoxetine

Additional relevant MeSH terms:
Anorexia Nervosa
Anorexia
Eating Disorders
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014