Kappa Opioid Receptor Imaging in Anorexia

NCT ID: NCT02240797

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Anorexia Nervosa - Recovered (AN-REC)

Anorexia Nervosa - Recovered (AN-REC)

Positron emission tomography (PET) imaging

Intervention Type OTHER

Positron emission tomography (PET) imaging

Healthy Control (HC)

Healthy Control (HC)

Positron emission tomography (PET) imaging

Intervention Type OTHER

Positron emission tomography (PET) imaging

Interventions

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Positron emission tomography (PET) imaging

Positron emission tomography (PET) imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


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

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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Marmar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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NYU School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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S13-00990

Identifier Type: -

Identifier Source: org_study_id

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