Major Depressive DisorderNCT02236702
Kappa Opioid Receptor Imaging in Depression (KOR Depression)
An observational study of Major Depressive Disorder and Anhedonia, 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 to measure the activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Anhedonia
- What is being tested?
- Positron Emission Tomography (PET) imaging
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
- 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).
Who cannot join
- 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;
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- 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.
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 to measure the activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed individuals.
Read the 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
- Being tested
- Positron Emission Tomography (PET) imaging
- Keywords
- Major Depressive Disorder, Anhedonia, Positron Emission Tomography (PET), Kappa Opioid Receptor (KOR)
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
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 |
|---|---|---|
| Asymptomatic control | Asymptomatic control Receives: Other: Positron Emission Tomography (PET) imaging | |
| Mildly symptomatic with depressive symptoms | Mildly symptomatic with depressive symptoms Receives: Other: Positron Emission Tomography (PET) imaging | |
| Moderately symptomatic with depressive symptoms | Moderately symptomatic with depressive symptoms Receives: Other: Positron Emission Tomography (PET) imaging | |
| Severely symptomatic with depressive symptoms | Severely symptomatic with depressive symptoms Receives: Other: Positron Emission Tomography (PET) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionFeb 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 Major Depressive DisorderStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Charles Marmar, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236702
- Sponsor's protocol ID
- S14-00643
- Status last verified
- Aug 2016
- First submitted
- 8 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 Depression (KOR Depression)
- ClinicalTrials.gov ID
- NCT02236702
- Acronym / sponsor ID
- S14-00643
- Conditions
- Major Depressive Disorder, Anhedonia
- Keywords
- Major Depressive Disorder, Anhedonia, Positron Emission Tomography (PET), Kappa Opioid Receptor (KOR)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic control | – | Other: Positron Emission Tomography (PET) imagingAsymptomatic control |
| Mildly symptomatic with depressive symptoms | – | Other: Positron Emission Tomography (PET) imagingMildly symptomatic with depressive symptoms |
| Moderately symptomatic with depressive symptoms | – | Other: Positron Emission Tomography (PET) imagingModerately symptomatic with depressive symptoms |
| Severely symptomatic with depressive symptoms | – | Other: Positron Emission Tomography (PET) imagingSeverely symptomatic with depressive symptoms |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
- 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).
Key exclusion criteria (15 listed)
- 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;
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 | Asymptomatic control, Mildly symptomatic with depressive symptoms, Moderately symptomatic with depressive symptoms, Severely symptomatic with depressive symptoms |
Primary outcome
[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.
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 Major Depressive Disorder and Anhedonia, 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 2 inclusion and 15 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?
[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). 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.