Anorexia NervosaNCT02240797
Kappa Opioid Receptor Imaging in Anorexia
An observational study of Anorexia Nervosa, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Positron emission tomography (PET) imaging
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anorexia Nervosa
- Being tested
- Positron emission tomography (PET) imaging
- Keywords
- Anorexia Nervosa, Neuroimaging, Positron emission tomography (PET), [11C]PKAB
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography (PET) imagingOther
Positron emission tomography (PET) imaging
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa - Recovered (AN-REC) | Anorexia Nervosa - Recovered (AN-REC) Receives: Other: Positron emission tomography (PET) imaging | |
| Healthy Control (HC) | Healthy Control (HC) Receives: Other: Positron emission tomography (PET) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Charles Marmar, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240797
- Sponsor's protocol ID
- S13-00990
- Status last verified
- Aug 2016
- First submitted
- 9 Sep 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kappa Opioid Receptor Imaging in Anorexia
- ClinicalTrials.gov ID
- NCT02240797
- Acronym / sponsor ID
- S13-00990
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Neuroimaging, Positron emission tomography (PET), [11C]PKAB
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Yale University, Icahn School of Medicine at Mount Sinai
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa - Recovered (AN-REC) | – | Other: Positron emission tomography (PET) imagingAnorexia Nervosa - Recovered (AN-REC) |
| Healthy Control (HC) | – | Other: Positron emission tomography (PET) imagingHealthy Control (HC) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron emission tomography (PET) imagingPositron emission tomography (PET) imaging | Other | Anorexia Nervosa - Recovered (AN-REC), Healthy Control (HC) |
Primary outcome
Volume of distribution (VT) (i.e., KOR binding) using [11C]PKAB and PET imaging
Time frame: Two months
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).
Results and safety
The study was stopped early (reason given: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Marmar, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of distribution (VT) (i.e., KOR binding) using [11C]PKAB and PET imaging (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.