Eating DisordersNCT00320684
Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa
An observational study of Eating Disorders and Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants will be women who have recovered from anorexia nervosa and are currently living in the local community.
Who may be able to join
- 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
- Female age 18-45
- BMI >18.5 kg/m
- Drug and medication free
- Willingness to engage in effective birth controls
Who cannot join
- 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
Show all 22Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: 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.
Read the 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
- Keywords
- Serotonin Transporter, Positron-Emission Tomography
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJul 2003
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Evelyn Attia, MD, Principal investigator, New York State Psyciatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320684
- Sponsor's protocol ID
- #4625/5767R
- Other IDs
- K23MH002021, DATR AK-TNNS1
- Status last verified
- Jun 2012
- First submitted
- 1 May 2006
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Positron Emission Tomography Study of the Serotonin Transporter in Weight-Restored Women With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00320684
- Acronym / sponsor ID
- #4625/5767R
- Conditions
- Eating Disorders, Anorexia Nervosa
- Keywords
- Serotonin Transporter, Positron-Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be women who have recovered from anorexia nervosa and are currently living in the local community.
Key inclusion criteria (8 listed)
- 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
- Female age 18-45
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
- Click here for the New York State Psychiatric Institute Eating Disorders Clinic websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyn Attia, MD principal investigator
New York State Psyciatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders and Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.