Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00320684

Purpose

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.

Condition
Eating Disorders Anorexia Nervosa

MedlinePlus related topics: Eating Disorders

Drug Information available for: Serotonin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	A Positron Emission Tomography Study of the Serotonin Transporter in Weight-Restored Women With Anorexia Nervosa

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	20
Study Start Date:	July 2003
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Women who have had anorexia nervosa but are now maintianing a healthy weight
2 Women who have never had anorexia nervosa and are maintianing a healthy weight

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Participants will be women who have recovered from anorexia nervosa and are currently living in the local community.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320684

Contacts

Contact: Danila Musante

212-543-6811

edru@pi.cpmc.columbia.edu

Locations

United States, New York
New York State Psychiatric Institute	Recruiting
New York, New York, United States, 10032
Contact: Ann F. Haynos 212-543-6811 edru@pi.cpmc.columbia.edu

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Evelyn Attia, MD

New York State Psyciatric Institute

More Information

Click here for the New York State Psychiatric Institute Eating Disorders Clinic website This link exits the ClinicalTrials.gov site

Responsible Party:	New York State Psychiatric Institute/Columbia University Medical Center ( Evelyn Attia, MD )
Study ID Numbers:	K23 MH02021, DATR AK-TNNS1
Study First Received:	May 1, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00320684
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Serotonin Transporter
Positron-Emission Tomography

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders

Anorexia
Anorexia Nervosa
Serotonin
Eating Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009