Kappa Opioid Receptor Imaging in Depression (KOR Depression)

NCT ID: NCT02236702

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-02-29

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.

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.

Conditions

Major Depressive Disorder; Anhedonia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Asymptomatic control

Asymptomatic control

Positron Emission Tomography (PET) imaging

Intervention Type: OTHER

Positron Emission Tomography (PET) imaging

Mildly symptomatic with depressive symptoms

Mildly symptomatic with depressive symptoms

Positron Emission Tomography (PET) imaging

Intervention Type: OTHER

Positron Emission Tomography (PET) imaging

Moderately symptomatic with depressive symptoms

Moderately symptomatic with depressive symptoms

Positron Emission Tomography (PET) imaging

Intervention Type: OTHER

Positron Emission Tomography (PET) imaging

Severely symptomatic with depressive symptoms

Severely symptomatic with depressive symptoms

Positron Emission Tomography (PET) imaging

Intervention Type: OTHER

Positron Emission Tomography (PET) imaging

Interventions

Positron Emission Tomography (PET) imaging

Positron Emission Tomography (PET) imaging

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Marmar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

S14-00643

Identifier Type: -

Identifier Source: org_study_id