Social DisconnectionNCT06705348
Social Disconnection Study
An observational study of Social Disconnection, run by Yale University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Disconnection
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- able to give written informed consent
- age 55+
- English speaking
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale Translational Brain Imaging Program
New Haven, Connecticut, 06510
Sarah Boster, MA, 203-737-7066, sarah.debonee@yale.edu
Nicole DellaGioia, MA, 2037376884, nicole.dellagioia@yale.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Disconnection
- Keywords
- loneliness, social disconnection, isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Social disconnection
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.
Measured: enrollment to end of study participation (approximately 1 year)
SV2A density
SV2A density as measured using [18F]SDM8 PET imaging.
Measured: enrollment to end of study participation (approximately 1 year)
Secondary outcomes (3)
Composite measure of suicide risk
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)
Measured: enrollment to end of study participation (approximately 1 year)
Sex
Measured: enrollment to end of study participation (approximately 1 year)
Composite measure of suicide risk over time
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).
Measured: 12-month study period (from scanning to year 1 follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start8 May 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social DisconnectionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Irina Esterlis, Yale University
- Investigators
- Irina Esterlis, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705348
- Sponsor's protocol ID
- 2000033973
- Other IDs
- 1R01MH132137-01
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Synaptic Density in Mediating the Relation Between Social Disconnection and Late-life Suicide Risk
- ClinicalTrials.gov ID
- NCT06705348
- Acronym / sponsor ID
- 2000033973
- Conditions
- Social Disconnection
- Keywords
- loneliness, social disconnection, isolation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 8 May 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 Nov 2024 (actual)
- 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- able to give written informed consent
- age 55+
- English speaking
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
SV2A density
Time frame: enrollment to end of study participation (approximately 1 year)
SV2A density as measured using [18F]SDM8 PET imaging.
3 secondary outcomes
Composite measure of suicide risk
Time frame: enrollment to end of study participation (approximately 1 year)
Sex
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Related trials for Social Disconnection
Active, not recruitingPhase 2
Pramipexole to Enhance Social Connections
Anxiety Disorders, Anxiety
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.
Irina Esterlis, Ph.D. principal investigator
Yale University
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 Social Disconnection, run by Yale University 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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Boster, MA (203-737-7066, Sarah.debonee@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social disconnection (time frame: enrollment to end of study participation (approximately 1 year)). The study lists 2 primary outcomes in all. 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 14 Aug 2026.