Clinical trial NCT02240797: Kappa Opioid Receptor Imaging in Anorexia
Official title: Kappa Opioid Receptor Imaging in Anorexia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Neuroimaging
Positron emission tomography (PET)
[11C]PKAB
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Yale University
name: Icahn School of Medicine at Mount Sinai
First posted: 2014-09-16
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are female, between the age range of 18 to 55, are medically healthy and currently not taking any medications to treat any medical illness, and have a history of anorexia nervosa and are recovered or never had a history of anorexia nervosa.

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Volume of distribution (VT) (i.e., KOR binding) using [11C]PKAB and PET imaging
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Charles Marmar, MD
role: PRINCIPAL_INVESTIGATOR
References: