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Kappa Opioid Receptor Imaging in Depression (KOR Depression)

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ClinicalTrials.gov Identifier: NCT02236702
Recruitment Status : Terminated (The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.)
First Posted : September 10, 2014
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Major Depressive Disorder Anhedonia Other: Positron Emission Tomography (PET) imaging

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
Actual Enrollment : 15 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Kappa Opioid Receptor Imaging in Depression (KOR Depression)
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Asymptomatic control
Asymptomatic control
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging

Mildly symptomatic with depressive symptoms
Mildly symptomatic with depressive symptoms
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging

Moderately symptomatic with depressive symptoms
Moderately symptomatic with depressive symptoms
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging

Severely symptomatic with depressive symptoms
Severely symptomatic with depressive symptoms
Other: Positron Emission Tomography (PET) imaging
Positron Emission Tomography (PET) imaging




Primary Outcome Measures :
  1. [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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236702


Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Yale University
Investigators
Principal Investigator: Charles Marmar, MD NYU School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02236702     History of Changes
Other Study ID Numbers: S14-00643
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by New York University School of Medicine:
Major Depressive Disorder
Anhedonia
Positron Emission Tomography (PET)
Kappa Opioid Receptor (KOR)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Anhedonia
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents