Kappa Opioid Receptor Imaging in Depression (KOR Depression)

August 15, 2016 updated by: NYU Langone Health
The purpose of this study is to use positron emission tomography (PET) imaging to measure the activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed individuals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The kappa opioid receptor (KOR) has been implicated in the etiology of fear, threat, and anhedonia in animal models of human depression psychopathology. Herein, we propose to study the KOR in vivo using positron emission tomography, and we will also measure the activity of the hypothalamic-pituitary-adrenal (HPA)-axis in all study participants. We propose to recruit up to N=50 medication-free individuals using a transdiagnostic approach, measure their KOR-selective radioligand [11C]LY2795050 volumes of distribution (VT), an equivalent of KOR availability using positron emission tomography (PET) and study the role of the KOR in mediating the quality and severity of the depressive phenotype.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are between the ages of 18-55, are medically healthy and not currently taking any medications to treat any medical illness, have been diagnosed with major depressive disorder (MDD) or will be as a result of this study, or are healthy control.

Description

Inclusion Criteria:

  1. Inclusion criteria for all subjects include a willingness to participate in a psychiatric evaluation, collection of behavioral ratings and neuroendocrine assessments, and imaging studies including 1 positron emission tomography (PET) scan and 1 mantic resonance imaging (MRI) scan.
  2. We propose to use a transdiagnostic approach where participants will be stratified according to their symptom severity to have a full representation of different depressive severities and components of the depressive phenotype in the cohort. To ensure recruitment of participants from each level of this phenotype, we will employ a stratified sampling approach to recruit 12 participants who are asymptomatic (i.e., Montgomery-Asberg Depression Rating Scale (MADRS) score=0-6); 12 who are mildly symptomatic (i.e., MADRS score=7-19; 12 who are moderately symptomatic (i.e., MADRS sore=20-34); and 12 who are severely symptomatic (i.e., MADRS score>34).

Exclusion Criteria:

  1. any major medical (including HIV due to possible neuropsychiatric affects; and asthma or heart disease which may limit the interpretation of the imaging results, for example due to changes in tracer delivery in hypertensive patients or significant weight change in prior 12 weeks prior to the study) and neurological illness or injury (i.e. head trauma with loss of consciousness);
  2. any current or prior clinically significant substance use disorder (abuse and dependence within a year from imaging studies) as determined by Structured Clinical Interview for Diagnostic and Statistical Manual Disorders (SCID) interview;
  3. acute or chronic suicidality as determined by the SCID interview;
  4. presence of any legal or illegal psychoactive substances determined with urine toxicology, urine cotinine, carbon monoxide (CO) monitoring, and breathalyzer;
  5. intelligence quotient (IQ) <70 based on past intelligence testing;
  6. any metal in body that would pose a risk with MRI;
  7. claustrophobia that would interfere with MRI or PET imaging;
  8. pregnancy or nursing for women;
  9. women with estrogen and/or progesterone levels outside the normal range, on birth control pills, peri- and post- menopausal women, and those with ovarectomies;
  10. obesity as defined by a body mass index (BMI) of > 35;
  11. use of psychoactive medications including regular use of benzodiazepines;
  12. having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participation in the study;
  13. life-time history of use and abuse of opioids; and
  14. presence of psychotic symptoms in patients with mood and anxiety disorders, schizophrenia or schizoaffective disorders; and
  15. blood donation within 8 weeks prior to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asymptomatic control
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging
Mildly symptomatic with depressive symptoms
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging
Moderately symptomatic with depressive symptoms
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging
Severely symptomatic with depressive symptoms
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[11C]LY2795050 volume of distribution (VT) values in specific brain regions of asymptomatic vs mildly symptomatic vs moderately symptomatic vs severely symptomatic individuals
Time Frame: one month
To use the KOR radioligand [11C]LY2795050 and PET to examine the relation between KOR availability in the ventral striatum and amygdala, and the full dimensional spectrum of threat and loss symptomatology, and reward responsiveness.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Yale University

Investigators

  • Principal Investigator: Charles Marmar, MD, NYU School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S14-00643

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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