Kappa Opioid Receptor Imaging in Anorexia



Status:Terminated
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:September 2014
End Date:March 2016

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The purpose of this study is to use positron emission tomography (PET) imaging and magnetic
resonance imaging (MRI) to understand the brain function of individuals with anorexia
nervosa and healthy controls.

This is a 3-year study involving n=7 women with anorexia nervosa - recovered (AN-REC) from
restricting subtype that have achieved a body mass index (BMI) > 18.5 in the past year, are
medication free, range in age from 18-55 years and n=7 healthy (medical and psychiatric
statues) age- and weight-matched controls who are invited to participate in a medical and
psychiatric evaluation, neuroendocrine assessments, one magnetic resonance imaging (MRI)
study and one positron emission tomography (PET) study kappa opioid receptor (KOR) 11-carbon
(11C) [11C]PKAB and PET. Subjects will be asked to provide written informed consent after
full explanation of all study procedures and risks and benefits related to study
participation. On the screening day a full medical evaluation including blood work, urine
analyses, toxicology, electrocardiogram (ECG) and physical exam will be performed.

Inclusion criteria for anorexic patients:

1. Able to understand the consent form document

2. A willingness to participate in a psychiatric evaluation, collection of behavioral
ratings and neuroendocrine assessments, and imaging studies including 1 PET scan and
1 MRI scan

3. Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
Anorexia Nervosa (AN)

4. Subjects will be between 18 and 55 years of age

5. Currently weight restored with a body mass index (BMI) > 18.5 for longer than 3
months

Inclusion criteria for healthy controls:

1. Able to understand the consent form document

2. A willingness to participate in a psychiatric evaluation, collection of behavioral
ratings and neuroendocrine assessments, and imaging studies including 1 PET scan and
1 MRI scan

3. Subjects will be between 18 and 55 years of age

4. Regular menstruation and no personal or first-degree family history of any Axis I
diagnosis based on DSM-IV criteria

Exclusion criteria for anorexic patients:

1. Any major neurological illness or injury

2. Presence of any legal or illegal psychoactive substances determined with urine
toxicology, and breathalyzer test for alcohol

3. Any significant unstable medical condition such as asthma or heart disease which may
limit the interpretation of the imaging results, for example due to changes in tracer
delivery in hypertensive patients

4. Intelligence quotient (IQ)<70 based on past intelligence

5. Any metal in body that would pose a risk with MRI

6. Claustrophobia that would interfere with MRI or PET imaging

7. Currently pregnant or nursing

Exclusion criteria for healthy controls:

1. Any major neurological illness or injury

2. Presence of any legal or illegal psychoactive substances determined with urine
toxicology, and breathalyzer test for alcohol

3. Any significant unstable medical condition such as asthma or heart disease which may
limit the interpretation of the imaging results, for example due to changes in tracer
delivery in hypertensive patients

4. IQ<70 based on past intelligence

5. Any metal in body that would pose a risk with MRI

6. Claustrophobia that would interfere with MRI or PET imaging

7. Currently pregnant or nursing
We found this trial at
1
site
New York, New York 10016
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New York, NY
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