Kappa Opioid Receptor Imaging in Anorexia

NYU Langone Health

Status: Terminated

Conditions: Anorexia Nervosa

Treatments: Other: Positron emission tomography (PET) imaging

Study type: Observational

Funder types: Other

Identifiers

NCT02240797

S13-00990

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

7 participants in 2 patient groups

Anorexia Nervosa - Recovered (AN-REC)

Description:

Anorexia Nervosa - Recovered (AN-REC)

Treatment:

Other: Positron emission tomography (PET) imaging

Healthy Control (HC)

Description:

Healthy Control (HC)

Treatment:

Other: Positron emission tomography (PET) imaging