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TerminatedNCT02240797Updated Aug 17, 2016

Kappa Opioid Receptor Imaging in Anorexia

An observational study in Anorexia Nervosa, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-17.

Sponsored by NYU Langone Health · Observational

Why this study was terminated
The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
7
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anorexia Nervosa

Keywords

  • Anorexia Nervosa
  • Neuroimaging
  • Positron emission tomography (PET)
  • [11C]PKAB
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 7 is below the median of 65 across 104 observational studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
7 participants (actual)
Patient registry
No

Groups and cohorts

  • Anorexia Nervosa - Recovered (AN-REC)

    Anorexia Nervosa - Recovered (AN-REC)

    Other: Positron emission tomography (PET) imaging

  • Healthy Control (HC)

    Healthy Control (HC)

    Other: Positron emission tomography (PET) imaging

Interventions

  • OtherPositron emission tomography (PET) imaging

    Positron emission tomography (PET) imaging

06

What researchers measure

Primary outcomes

  1. Volume of distribution (VT) (i.e., KOR binding) using [11C]PKAB and PET imaging

    In this study we are using the KOR radioligand \[11C\]PKAB and PET to investigate group differences in cerebral KOR binding potential in 7 AN-REC and 7 healthy controls (HCs).

    Time frame: Two months

07

Study locations

1 site
  • NYU School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02240797
Lead sponsor
NYU Langone Health
Collaborators
Yale University, Icahn School of Medicine at Mount Sinai
Responsible party
Sponsor
First posted
Sep 16, 2014
Start date
Sep 2014
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Aug 17, 2016

Study contacts

Charles Marmar, MD
principal investigator · NYU School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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