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Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00320684
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 2, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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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.

Condition or disease
Eating Disorders Anorexia Nervosa

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 Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Positron Emission Tomography Study of the Serotonin Transporter in Weight-Restored Women With Anorexia Nervosa
Study Start Date : July 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Groups and Cohorts
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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


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320684


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Evelyn Attia, MD New York State Psyciatric Institute
More Information
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Additional Information:

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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00320684    
Other Study ID Numbers: #4625/5767R
K23MH002021 ( U.S. NIH Grant/Contract )
DATR AK-TNNS1
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012
Keywords provided by New York State Psychiatric Institute:
Serotonin Transporter
Positron-Emission Tomography
Additional relevant MeSH terms:
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Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive