Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa

NCT ID: NCT00320684

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2009-06-30

Brief Summary

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.

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.

Conditions

Eating Disorders; Anorexia Nervosa

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Women who have had anorexia nervosa but are now maintaining a healthy weight

No interventions assigned to this group

2

Women who have never had anorexia nervosa and are maintaining a healthy weight

No interventions assigned to this group

Eligibility 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
• Off all psychotropic and other types of medications likely to impact the serotonin system for at least 21 days

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

Inclusion for Healthy Controls:

• Female age 18-45
• BMI >18.5 kg/m
• Drug and medication free
• Willingness to engage in effective birth controls

Exclusion for Healthy Controls

• History of any DSM-IV Axis - I diagnosis
• History of Axis II disorder that would be accompanied by impulse control problems or significant suicidal behavior
• Significant active physical illness
• Lacks capacity to consent
• Pregnancy, currently lactating
• Metal implants, pacemaker or metal prostheses or orthodontic appliances or shrapnel
• Current, past radiation exposure in the workplace or as part of a research protocol in the previous year or badged for radiation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evelyn Attia, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psyciatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Related Links

http://www.columbiaeatingdisorders.org

Click here for the New York State Psychiatric Institute Eating Disorders Clinic website

Other Identifiers

K23MH002021

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DATR AK-TNNS1

Identifier Type: -

Identifier Source: secondary_id

#4625/5767R

Identifier Type: -

Identifier Source: org_study_id