Social Disconnection Study

June 4, 2026 updated by: Irina Esterlis, Yale University

Role of Synaptic Density in Mediating the Relation Between Social Disconnection and Late-life Suicide Risk

The purpose of this research study is to examine the effect of social connectedness on the brain. Study procedures include one Magnetic Resonance Imaging (MRI) or functional Magnetic Resonance Imaging (fMRI) scan, one Positron Emission Tomography (PET) scan, one Magnetic Resonance Spectroscopy (MRS) scan, an electroencephalogram (EEG), and in-person and phone call follow-ups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The purpose of this study is to examine the effect of social connectedness (social isolation and loneliness) on synaptic density in the brain using PET scans. Participants will have a screening appointment to determine eligibility. Participants will participate in the following study procedures:

MRI or fMRI scan: the purpose of the MR scan is to help us identify the different regions of the brain on the PET scans. Participants may be asked to do some cognitive and behavioral tasks during parts of the MR scan.

PET scan: an arterial catheter and one or two IV catheters will be placed (one for radiotracer injection and one to take blood samples). The radiotracer, [18F]SDM-8 will be used. A radiotracer is a minimal amount of a drug that is labeled with a very small amount of a radioactive substance that binds to receptors in the brain and can be detected by a special camera in the PET scanner.

Electroencephalography (EEG): EEG is a procedure that allows measurement of physiological brain responses. Sensors placed on and around the head record small electrical currents produced by the brain.

Follow-up phone calls and appointments: participants will have follow-up phone calls every 3 months for 9 months following scan visits, and an in-person follow-up appointment 1 year after scans to assess mood and cognition, as well as document any changes. Follow-up assessments may continue for up to 5 years after the year one follow-up appointment.

Some subjects may be asked to return after the 1 year follow-up period to repeat study procedures to examine changes over time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Translational Brain Imaging Program
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irina Esterlis, Ph.D.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Transdiagnostic sample of older individuals (age 55+ years) with stress disorders without psychosis including individuals with MDD, bipolar disorder, post-traumatic stress disorder (PTSD), dysthymia, and non-psychiatric individuals.

Description

Inclusion Criteria:

  • able to give written informed consent
  • age 55+
  • English speaking

Exclusion Criteria:

  • contraindication to MRI scanning including claustrophobia, high girth, moderate to significant white matter atrophy, and presence of ferromagnetic material in the body, including orthodontic braces or other non MR-compatible foreign bodies. All participants will be screened for metal objects by the same methods used for routine clinical MRI scanning
  • for women: pregnancy or breastfeeding
  • serious medical or neurological illness that in the opinion of the PI would interfere with the scientific goals of the study or participant safety
  • pervasive developmental disorders (PDD) or primary psychotic disorders
  • meet DSM-5 criteria for current severe substance use disorder (except marijuana or nicotine)
  • head injury that led to significant long term decline in cognitive abilities as seen by decline in grades or work performance
  • current psychosis, active significant suicidal (score of 6 on MADRS suicide item) or homicidal ideation
  • lifetime history of neurologic abnormality including seizure disorder, cerebrovascular, or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia >24 hours
  • full scale IQ lower than 70
  • contraindications to PET (e.g. poor venous access for placement of venous lines)
  • history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
  • history of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) *for subjects obtaining arterial line.
  • blood donation within 8 weeks of the start of the study
  • REM sleep disorder
  • brain injury (TBI, seizure/epilepsy, stroke, TIA) in lifetime (self-report and medical chart review)
  • electroconvulsive or ketamine therapy, or similar therapies that have rapid effects on brain neurochemistry within the past 6 months
  • high risk for stroke (above first quartile on Framingham Stroke Risk Profile)
  • current cancer

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Transdiagnostic
Participants will be a transdiagnostic sample of older individuals (age 55+ years) with stress disorders without psychosis including individuals with MDD, bipolar disorder, post-traumatic stress disorder (PTSD), dysthymia, and non-psychiatric individuals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Social disconnection
Time Frame: enrollment to end of study participation (approximately 1 year)

Social disconnection composite measure determined by the following:

Item #3 - Hamilton Depression Rating Scale (social withdrawal; range = 0-4) Item #12 - Beck Depression Inventory-II (loss of interest in people; range = 0-3) Item #14 - Center for Epidemiologic Studies Depression Scale (feelings of loneliness; range = 0-3) Item #2 - Snaith-Hamilton Pleasure Scale (enjoyment being with family or close friends; range = 0-1) Item #7 - Snaith-Hamilton Pleasure Scale (enjoyment seeing other people's smiling faces; range = 0-1) Item #17 - Profile of Mood States (loneliness; range = 0-4)

Higher composite score = greater severity of social disconnection.
enrollment to end of study participation (approximately 1 year)
SV2A density
Time Frame: enrollment to end of study participation (approximately 1 year)
SV2A density as measured using [18F]SDM8 PET imaging.
enrollment to end of study participation (approximately 1 year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite measure of suicide risk
Time Frame: enrollment to end of study participation (approximately 1 year)

Suicide risk will be operationalized as a composite score of death ideation, depressive symptoms, loss of personal and self-worth, executive control, and perceived meaning in life based on the following:

Geriatric Suicide Ideation Scale (GSIS) suicide ideation subscale score (range 10-50, higher score indicates greater active suicidal ideation).

GSIS death ideation subscale score (range 5-25, higher score indicates greater death ideation) Montgomery Asberg Depression Rating Scale (MADRS) total score (range 0-60, higher score indicates greater severity of depression) GSIS loss of personal and social worth subscale score (range 7-35, higher score indicates greater feeling of loss of personal and social worth) Cogstate Go/No-Go task score GSIS perceived meaning in life subscale score (range 8-40, higher score indicates lower perceived meaning in life)
enrollment to end of study participation (approximately 1 year)
Sex
Time Frame: enrollment to end of study participation (approximately 1 year)
enrollment to end of study participation (approximately 1 year)
Composite measure of suicide risk over time
Time Frame: 12-month study period (from scanning to year 1 follow-up)
identification of predominant trajectories of suicide risk measures (see 'composite measure of suicide risk' outcome measure) over 5 time points spanning the 12-month study period (0, 3, 6, 9, and 12 months).
12-month study period (from scanning to year 1 follow-up)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Irina Esterlis, Ph.D., Yale University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000033973

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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