Kappa Opioid Receptor Imaging in Anorexia

Anorexia Nervosa Clinical Trial

Official title:

Kappa Opioid Receptor Imaging in Anorexia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02240797
• Other study ID #: S13-00990
• Status: Terminated
• Phase: N/A
• First received: September 9, 2014
• Last updated: August 15, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Positron emission tomography (PET) imaging
Positron emission tomography (PET) imaging

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Icahn School of Medicine at Mount Sinai, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No