Kappa Opioid Receptor Imaging in Depression (KOR Depression)

NCT02236702 | Terminated DMC

• 1 other identifier: S14-00643
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Anhedonia

Keywords

Major Depressive Disorder; Anhedonia; Positron Emission Tomography (PET); Kappa Opioid Receptor (KOR)

Outcome Measures

Primary Outcomes (1)

• [11C]LY2795050 volume of distribution (VT) values in specific brain regions of asymptomatic vs mildly symptomatic vs moderately symptomatic vs severely symptomatic individuals

  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

Study Arms (4)

Asymptomatic control

Asymptomatic control

Other: Positron Emission Tomography (PET) imaging

Mildly symptomatic with depressive symptoms

Mildly symptomatic with depressive symptoms

Other: Positron Emission Tomography (PET) imaging

Moderately symptomatic with depressive symptoms

Moderately symptomatic with depressive symptoms

Other: Positron Emission Tomography (PET) imaging

Severely symptomatic with depressive symptoms

Severely symptomatic with depressive symptoms

Other: Positron Emission Tomography (PET) imaging

Interventions

Positron Emission Tomography (PET) imaging OTHER

Positron Emission Tomography (PET) imaging

Asymptomatic control; Mildly symptomatic with depressive symptoms; Moderately symptomatic with depressive symptoms; Severely symptomatic with depressive symptoms

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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);
• 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;
• acute or chronic suicidality as determined by the SCID interview;
• presence of any legal or illegal psychoactive substances determined with urine toxicology, urine cotinine, carbon monoxide (CO) monitoring, and breathalyzer;
• intelligence quotient (IQ) \<70 based on past intelligence testing;
• any metal in body that would pose a risk with MRI;
• claustrophobia that would interfere with MRI or PET imaging;
• pregnancy or nursing for women;
• women with estrogen and/or progesterone levels outside the normal range, on birth control pills, peri- and post- menopausal women, and those with ovarectomies;
• obesity as defined by a body mass index (BMI) of \> 35;
• use of psychoactive medications including regular use of benzodiazepines;
• 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;
• life-time history of use and abuse of opioids; and
• presence of psychotic symptoms in patients with mood and anxiety disorders, schizophrenia or schizoaffective disorders; and
• blood donation within 8 weeks prior to the study.

Sponsors & Collaborators

• NYU Langone Health: lead
• Yale University: collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anhedonia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Charles Marmar, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: February 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)