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Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa
This study is currently recruiting participants.
Study NCT00320684   Information provided by National Institute of Mental Health (NIMH)
First Received: May 1, 2006   Last Updated: April 23, 2009   History of Changes

May 1, 2006
April 23, 2009
July 2003
June 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00320684 on ClinicalTrials.gov Archive Site
 
 
 
Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa
A Positron Emission Tomography Study of the Serotonin Transporter in Weight-Restored Women With Anorexia Nervosa

This study will compare the concentrations of serotonin transporter in the brains of women with a history of anorexia nervosa who are currently maintaining a normal weight to those of healthy women of normal weight.

Anorexia nervosa (AN) is a serious eating disorder that is associated with substantial morbidity and mortality. Despite being dangerously underweight, people with AN believe that they are overweight, and frequently exhibit symptoms of depression and anxiety. Other symptoms of AN include the following: resistance to maintaining a healthy body weight; fear of gaining weight or becoming overweight; and denial of the seriousness of one's current low body weight. Relapse rates for AN are extremely high. Serotonin is a neurotransmitter, or chemical messenger, that affects mood, impulse control, and appetite. A serotonin transporter is a specialized protein that allows cells to communicate with each other by using serotonin. Disturbances in the serotonergic system, the network of nerve cells that uses serotonin as its neurotransmitter, may contribute to the behaviors that are characteristic of AN. This study will compare women with a history of AN who are now maintaining a normal weight to healthy women of normal weight in terms of the concentration of serotonin transporter in their brains.

Participants in this observational study will undergo one positron emission tomography (PET) scan and one magnetic resonance imaging (MRI) scan. Both will be used to measure the concentration of the serotonin transporter. A radioactive tracer will be used for the PET scan, and will be administered via an intravenous catheter line. No treatment will be provided in this study.

 
Observational
Case Control, Prospective
  • Eating Disorders
  • Anorexia Nervosa
 
  • Women who have had anorexia nervosa but are now maintianing a healthy weight
  • Women who have never had anorexia nervosa and are maintianing a healthy weight
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of anorexia nervosa
  • BMI has been greater than 18.5 kg/m² for at least 9 months
  • Agrees to use an effective method of contraception

Exclusion Criteria:

  • Use of any psychotropic medication or other types of medications that are likely to affect the serotonin system within 21 days of study entry
  • Current DSM-IV Axis-I diagnosis of any illness other than an eating disorder
  • Current AN or history of AN within 9 months prior to study entry
  • Presence of any psychiatric symptom that would make participation unsafe
  • Significant active physical illnesses, particularly those that may affect the brain or serotonergic system, including the following: blood dyscrasias lymphomas; hypersplenism; endocrinopathies; renal failure or chronic obstructive lung disease; autonomic neuropathies; low hemoglobin; anemia; peripheral vascular disease; and malignancy
  • Currently receiving effective medication treatment for an eating disorder
  • History of Raynaud's phenomena and/or acrocyanosis
  • Significant regular tobacco use (defined as more than 1 pack per week)
  • Lacks capacity to consent
  • Pregnant
  • Breastfeeding
  • Any metal implants, pacemaker, metal prostheses, orthodontic appliances, or the presence of shrapnel
  • Significant history of claustrophobia that would complicate the completion of MRI
  • Current or past radiation exposure in the workplace or as part of a research protocol in the previous year
  • Badged for radiation
Female
18 Years to 45 Years
Yes
Contact: Danila Musante 212-543-6811 edru@pi.cpmc.columbia.edu
United States
 
NCT00320684
Evelyn Attia, MD, New York State Psychiatric Institute/Columbia University Medical Center
K23 MH002021, DATR AK-TNNS1
National Institute of Mental Health (NIMH)
 
Principal Investigator: Evelyn Attia, MD New York State Psyciatric Institute
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP