Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa

June 28, 2012 updated by: New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Women who have had anorexia nervosa but are now maintaining a healthy weight
2
Women who have never had anorexia nervosa and are maintaining a healthy weight

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Evelyn Attia, MD, New York State Psyciatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4625/5767R
  • K23MH002021 (U.S. NIH Grant/Contract)
  • DATR AK-TNNS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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