NCT02240797

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

September 9, 2014

Last Update Submit

August 15, 2016

Conditions

Anorexia Nervosa

Keywords

Anorexia NervosaNeuroimagingPositron emission tomography (PET)[11C]PKAB

Outcome Measures

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).

    Two months

Study Arms (2)

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

Positron emission tomography (PET) imagingOTHER

Positron emission tomography (PET) imaging

Anorexia Nervosa - Recovered (AN-REC)Healthy Control (HC)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Able to understand the consent form document
  • 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
  • Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Anorexia Nervosa (AN)
  • Subjects will be between 18 and 55 years of age
  • Currently weight restored with a body mass index (BMI) \> 18.5 for longer than 3 months
  • Able to understand the consent form document
  • 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
  • Subjects will be between 18 and 55 years of age
  • Regular menstruation and no personal or first-degree family history of any Axis I diagnosis based on DSM-IV criteria

You may not qualify if:

  • Any major neurological illness or injury
  • Presence of any legal or illegal psychoactive substances determined with urine toxicology, and breathalyzer test for alcohol
  • 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
  • Intelligence quotient (IQ)\<70 based on past intelligence
  • Any metal in body that would pose a risk with MRI
  • Claustrophobia that would interfere with MRI or PET imaging
  • Currently pregnant or nursing
  • Any major neurological illness or injury
  • Presence of any legal or illegal psychoactive substances determined with urine toxicology, and breathalyzer test for alcohol
  • 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
  • IQ\<70 based on past intelligence
  • Any metal in body that would pose a risk with MRI
  • Claustrophobia that would interfere with MRI or PET imaging
  • Currently pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Charles Marmar, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(1)