Schizophrenia and Related DisordersSIASNCT07419321
Social Isolation and Aging in Schizophrenia
An observational study of Schizophrenia and Related Disorders, run by Icahn School of Medicine at Mount Sinai at 4 sites in 4 countries.
Trial summary
Individuals diagnosed with schizophrenia and related psychotic disorders (SZ) exhibit a markedly elevated risk of premature mortality, with a 10-20-year shorter lifespan relative to the general population. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Related Disorders
- How many people
- 650 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 9 Jan 2024to Jul 2027
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 500 clinically stable schizophrenia participants, and 150 of their unaffected siblings from a list of eligible participants of large existing studies of schizophrenia: e.g. EUropean network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) and large scale research studies that took place at the Olin Neuropsychiatry Research Center, Institute of Living, Hartford, CT. All participants consented to be recruited for future studies.
Who may be able to join
- DSM-IV or V diagnosis of a SZ related disorder (295.x, 297.1, 298.8, or 298.9; e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, but not psychotic disorder that is solely substance induced) based on clinical interview;
- Between 40 and 70 years of age at time of study recruitment;
- Participant was enrolled in a previous research study between the ages of 20-55, and this study took place at least 5 years ago;
- Able to understand the spoken language of the participating country sufficiently to comprehend testing procedures;
- No history of serious head injury (i.e., loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury);
- No history of IQ < 70, or developmental disability based on chart review;
Show all 15Show fewer
- Clinically stable (i.e., no inpatient hospitalizations for three months prior to enrollment, no changes in medication in the four weeks prior to enrollment;
- The inclusion and exclusion criteria for sibling participants in this study will be:
- No history of any DSM IV/V Axis I or axis II diagnosis that is known to be associated with social functioning (e.g. severe mood disorder, schizoaffective personality disorder, autism spectrum disorder);
- Between 40 and 70 years of age at time of study recruitment;;
- Participant was enrolled in a previous research study between the ages of 20-55, and this study took place at least 5 years ago;
- Able to understand the spoken language of the participating country sufficiently to comprehend testing procedures;
- No history of serious head injury (i.e., loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury);
- No history of IQ < 70, or developmental disability based on chart review;
- Clinically stable (i.e., no inpatient hospitalizations for three months prior to enrollment, no changes in medication in the four weeks prior to enrollment
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
United States1 site, 1 recruiting
- Recruiting
Olin Neuropsychiatry Research Center, Hartfort
Hartford, Connecticut, 06106
Michael Stevens, PhD, 860-545-7800, michael.stevens@hhchealth.org
Netherlands1 site, 1 recruiting
- Recruiting
AUMC, University Hospital
Amsterdam, North Holland, 1105AZ
Lieuwe de Haan, PhD, +31 20 8913600, l.dehaan@amsterdamumc.nl
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28030
Celso Arango, PhD, +34 913283209, carango@hggm.es
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, Se58AF
Craig Morgan, PhD, +44 2078480351, craig.morgan@kcl.ac.uk
About this study
Official title: The Impact of Social Isolation on Aging Health in Schizophrenia
Individuals diagnosed with schizophrenia and related psychotic disorders (SZ) exhibit a markedly elevated risk of premature mortality, with a 10-20-year shorter lifespan relative to the general population. Increased mortality rates in SZ are largely attributable to the early manifestation of medical conditions that normally occur later in life, a process known as 'accelerated aging'. While unhealthy lifestyle behaviors, such as smoking and unhealthy diet, account, in part, for accelerated aging in SZ, the excess of physical comorbidities cannot be solely attributed to these factors. Remarkably, the direct adverse health effects of key clinical characteristics of SZ have rarely been considered. In the general population, the absence of social contact is known to pose enormous challenges for physical health, especially at older ages. Given that social isolation is a persistent and disabling feature of SZ, it is possible that this behavior may contribute to the premature manifestation of health conditions in SZ. Building on rich pilot data pointing to significant associations between social isolation and long-term perceived health in SZ, the overarching goal is to test whether and how social isolation contributes to the health challenges of individuals with SZ as they age. With participants from Europe (EU-GEI) and the US (Olin Neuropsychiatry Research Center), the researchers will create a longitudinal database of 650 participants, including 500 individuals with SZ, and 150 of their unaffected siblings. The researchers will apply an accelerated longitudinal design by reassessing and by examining medical records of research participants who were first evaluated between the ages of 20-55 and are now 40-70 years of age, a period when many medical conditions and health problems tend to manifest. The researchers will determine the age-related association between social isolation and adverse health outcomes in SZ, test for familiality, directionality, and factors moderating this association, and determine the extent to which the COVID-19 pandemic and the resulting imposed lockdowns impacted health in SZ. The researchers will consider generalizability across countries, sexes, and race/ethnicities. The rationale for the proposed research is that in order to facilitate much-needed targeted therapies to prevent early mortality in SZ, the researchers need to better understand factors that contribute to the excess of medical comorbidities in SZ. The central hypothesis is that social isolation, a common and persistent characteristic of SZ, contributes to the excess of physical comorbidities in SZ. To meet the overall goal, the following aims are: (1) Determine the association between social isolation and adverse health outcomes in SZ; (2) Test for the directionality, and moderating factors, of the association between social isolation and health outcomes in SZ, and; (3) Examine whether the COVID-19 pandemic modified associations between social isolation and health outcome in SZ. This study will be the first to comprehensively examine the health impact of social isolation in SZ. The project may show that in SZ socialization in midlife can reduce the risk for poor health outcomes and ultimately facilitate much-needed preventive targeted therapies to reduce early-age mortality in SZ
Read the detailed description
An accelerated longitudinal design is employed, combining prior research data collected when participants were aged 20-55 with new follow-up assessments now that they are aged 40-70.
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- schizophrenia, psychosis, social isolation, physical health, longitudinal trajectory, siblings
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Social 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 |
|---|---|---|
| Individuals with SZ | Individuals with a schizophrenia-related diagnosis | |
| Unaffected first-degree relatives | Unaffected first-degree relatives of individuals with a schizophrenia-related diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of newly diagnosed conditions
Physician diagnosed medical conditions - Medical records from hospitals and general practitioners will be reviewed to identify the occurrence and timing of any newly diagnosed conditions (e.g., cardiovascular disease, COPD, diabetes).
Measured: Day 1
Short Form Health Survey (SF-36),
The 36-Item Short Form Health Survey (SF-36), which includes five physical domains: physical functioning, role limitations due to physical problems, bodily pain, general health, and vitality. The individuals item scores (scored between 1-60, according to the manual) are summed to scale scores and transformed to a 100-point scale, with higher scores indicating a better health status.
Measured: Day 1
Number of Participants with High Cholesterol
High cholesterol (defined as low-density lipoprotein ≥160 mg/dL or total cholesterol ≥240 mg/dL)
Measured: Day 1
Number of participants with High Blood Pressure
High blood pressure (defined as systolic ≥130 mm Hg or diastolic ≥80 mm Hg).
Measured: Day 1
Schedule for Deficit Syndrome (SDS)
Social isolation is measured with the Schedule for Deficit Syndrome (SDS) - each item scored from 0 (normal) to 4 (severely impaired). there is also a global severity score (0 to 4). Full scale scored from 0 to 20, with higher score representing greater severity of symptoms.
Measured: Chart Review for the legacy data from when participants were first assessed between 2004 and 2015
The Birchwood social functioning scale (SFS)
Social isolation is measured with the Birchwood social functioning scale (SFS) - a 79 item instrument, and consists of seven subscales: (1) social engagement/withdrawal (amount of time to spend alone, the likelihood to initiate conversation); (2) interpersonal behaviour (number of friends, engagement in a romantic relationship); (3) prosocial activities (participation in social activities e.g. visit friends, play sports); (4) recreation (engagement in activities and hobbies); (5) independence-competence (ability to maintain independent living); (6) independence-performance (performance of the skills required for independent living); (7) employment/occupation (engagement in employment), The sum of each scale, and the full scale is standardized and normalized with a mean of 100 and standard deviation of 15. Higher scores represent better health outcomes.
Measured: Chart review for the legacy data from when participants were first assessed between 2004 and 2015; and Three times daily for 14 days
'Social Isolation' subscale of the Structured Interview for Schizotypy-Revised (SIS-R)
Social isolation is measured with the 'Social Isolation' subscale of the Structured Interview for Schizotypy-Revised (SIS-R). The subscale range from 0 (virtually no evidence of symptoms) to 6 (symptoms present and quite severe).
Measured: Chart review for the legacy data from when participants were first assessed between 2004 and 2015; and Three times daily for 14 days
Secondary outcomes (3)
The Revised UCLA Loneliness Scale (R-UCLA)
The Revised UCLA Loneliness Scale (R-UCLA) is a 20-item questionnaire. Every item is scored with a number that indicates how often each question is applicable (1 = Never, 2 = Rarely, 3 = Sometimes, and 4 = Always). To calculate the total score for each participant, all responses are summed to create a total score ranging from 20 to 80. Higher score indicates more loneliness.
Total score <28 = no/low loneliness Total score 28-43 = moderate loneliness Total score >43 = a high degree of loneliness.
Measured: Day 1
Ecological Momentary Assessment (EMA)
Severity of psychotic symptoms and functional impairments related to SZ of the EMA questions using "EMA-wellness". Scored from 0-12, with higher score indicating poorer health outcomes
Measured: Chart review legacy data; and 3 times daily for 14 days
Barriers to Access to Care Evaluation scale (BACE)
The Barriers to Access to Care Evaluation scale (BACE) questionnaire will be used to establish any problems related to access to healthcare over the years. The BACE is designed to assess barriers to mental health care for people with mental health problems. It includes barriers related to, and unrelated to, stigma and discrimination. It has 30 items, and is scored by summing responses to these items, where each item uses a 0 (not at all) to 3 (a lot) scale, full scale scored from 0-90, with higher scores indicating greater perceived barriers.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start9 Jan 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Other
- Time perspective
- Other
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Yale University, Hartford Hospital, Hospital General Universitario Gregorio Marañon, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), King's College London, University of Miami, Boston Children's Hospital, GGZ Noord-Holland-Noord, Karolinska Institutet
- Responsible party
- Principal investigator, Abraham Reichenberg, Icahn School of Medicine at Mount Sinai
- Investigators
- Abraham Reichenberg, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419321
- Sponsor's protocol ID
- STUDY-22-00730
- Other IDs
- 1R01MH128971-01A1
- Acronym
- SIAS
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study available in publications is shared via the NIMH National Data Archives (NDA) and is available in NDA collection C4431.
Publications
Koster M, van der Pluijm M, Baldwin H, Greenburgh A, King D, Arnold C, Lopez-Morinigo JD, Underwood S, Larrauri CA, Racher M, Glahn DC, Harvey PD, Sandin S, Stevens M, Pearlson G, Arango C, Dazzan P, Morgan C, de Haan L, Reichenberg A, Velthorst E. Social Isolation and Aging health in Schizophrenia spectrum disorders (SIAS): study protocol for a multinational longitudinal study. BMC Psychiatry. 2026 Mar 10;26(1):324. doi: 10.1186/s12888-026-07936-y.
PubMed 41808086
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Social Isolation on Aging Health in Schizophrenia
- ClinicalTrials.gov ID
- NCT07419321
- Acronym / sponsor ID
- SIAS / STUDY-22-00730
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- schizophrenia, psychosis, social isolation, physical health, longitudinal trajectory, siblings
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Yale University, Hartford Hospital, Hospital General Universitario Gregorio Marañon, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), King's College London, University of Miami, Boston Children's Hospital, GGZ Noord-Holland-Noord, Karolinska Institutet
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Feb 2026 (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.
Individuals diagnosed with schizophrenia and related psychotic disorders (SZ) exhibit a markedly elevated risk of premature mortality, with a 10-20-year shorter lifespan relative to the general population. Increased mortality rates in SZ are largely attributable to the early manifestation of medical conditions that normally occur later in life, a process known as 'accelerated aging'. While unhealthy lifestyle behaviors, such as smoking and unhealthy diet, account, in part, for accelerated aging in SZ, the excess of physical comorbidities cannot be solely attributed to these factors. Remarkably, the direct adverse health effects of key clinical characteristics of SZ have rarely been considered. In the general population, the absence of social contact is known to pose enormous challenges for physical health, especially at older ages. Given that social isolation is a persistent and disabling feature of SZ, it is possible that this behavior may contribute to the premature manifestation of health conditions in SZ. Building on rich pilot data pointing to significant associations between social isolation and long-term perceived health in SZ, the overarching goal is to test whether and how social isolation contributes to the health challenges of individuals with SZ as they age. With participants from Europe (EU-GEI) and the US (Olin Neuropsychiatry Research Center), the researchers will create a longitudinal database of 650 participants, including 500 individuals with SZ, and 150 of their unaffected siblings. The researchers will apply an accelerated longitudinal design by reassessing and by examining medical records of research participants who were first evaluated between the ages of 20-55 and are now 40-70 years of age, a period when many medical conditions and health problems tend to manifest. The researchers will determine the age-related association between social isolation and adverse health outcomes in SZ, test for familiality, directionality, and factors moderating this association, and determine the extent to which the COVID-19 pandemic and the resulting imposed lockdowns impacted health in SZ. The researchers will consider generalizability across countries, sexes, and race/ethnicities. The rationale for the proposed research is that in order to facilitate much-needed targeted therapies to prevent early mortality in SZ, the researchers need to better understand factors that contribute to the excess of medical comorbidities in SZ. The central hypothesis is that social isolation, a common and persistent characteristic of SZ, contributes to the excess of physical comorbidities in SZ. To meet the overall goal, the following aims are: (1) Determine the association between social isolation and adverse health outcomes in SZ; (2) Test for the directionality, and moderating factors, of the association between social isolation and health outcomes in SZ, and; (3) Examine whether the COVID-19 pandemic modified associations between social isolation and health outcome in SZ. This study will be the first to comprehensively examine the health impact of social isolation in SZ. The project may show that in SZ socialization in midlife can reduce the risk for poor health outcomes and ultimately facilitate much-needed preventive targeted therapies to reduce early-age mortality in SZ
Detailed description
An accelerated longitudinal design is employed, combining prior research data collected when participants were aged 20-55 with new follow-up assessments now that they are aged 40-70.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with SZ | – | –Individuals with a schizophrenia-related diagnosis |
| Unaffected first-degree relatives | – | –Unaffected first-degree relatives of individuals with a schizophrenia-related diagnosis |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 500 clinically stable schizophrenia participants, and 150 of their unaffected siblings from a list of eligible participants of large existing studies of schizophrenia: e.g. EUropean network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) and large scale research studies that took place at the Olin Neuropsychiatry Research Center, Institute of Living, Hartford, CT. All participants consented to be recruited for future studies.
Key inclusion criteria (15 listed)
- DSM-IV or V diagnosis of a SZ related disorder (295.x, 297.1, 298.8, or 298.9; e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, but not psychotic disorder that is solely substance induced) based on clinical interview;
- Between 40 and 70 years of age at time of study recruitment;
- Participant was enrolled in a previous research study between the ages of 20-55, and this study took place at least 5 years ago;
- Able to understand the spoken language of the participating country sufficiently to comprehend testing procedures;
- No history of serious head injury (i.e., loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury);
Key exclusion criteria (0 listed)
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
Occurrence of newly diagnosed conditions
Time frame: Day 1
Physician diagnosed medical conditions - Medical records from hospitals and general practitioners will be reviewed to identify the occurrence and timing of any newly diagnosed conditions (e.g., cardiovascular disease, COPD, diabetes).
Short Form Health Survey (SF-36),
Time frame: Day 1
The 36-Item Short Form Health Survey (SF-36), which includes five physical domains: physical functioning, role limitations due to physical problems, bodily pain, general health, and vitality. The individuals item scores (scored between 1-60, according to the manual) are summed to scale scores and transformed to a 100-point scale, with higher scores indicating a better health status.
Number of Participants with High Cholesterol
Time frame: Day 1
High cholesterol (defined as low-density lipoprotein ≥160 mg/dL or total cholesterol ≥240 mg/dL)
Number of participants with High Blood Pressure
Time frame: Day 1
High blood pressure (defined as systolic ≥130 mm Hg or diastolic ≥80 mm Hg).
Schedule for Deficit Syndrome (SDS)
Time frame: Chart Review for the legacy data from when participants were first assessed between 2004 and 2015
Social isolation is measured with the Schedule for Deficit Syndrome (SDS) - each item scored from 0 (normal) to 4 (severely impaired). there is also a global severity score (0 to 4). Full scale scored from 0 to 20, with higher score representing greater severity of symptoms.
The Birchwood social functioning scale (SFS)
Time frame: Chart review for the legacy data from when participants were first assessed between 2004 and 2015; and Three times daily for 14 days
Social isolation is measured with the Birchwood social functioning scale (SFS) - a 79 item instrument, and consists of seven subscales: (1) social engagement/withdrawal (amount of time to spend alone, the likelihood to initiate conversation); (2) interpersonal behaviour (number of friends, engagement in a romantic relationship); (3) prosocial activities (participation in social activities e.g. visit friends, play sports); (4) recreation (engagement in activities and hobbies); (5) independence-competence (ability to maintain independent living); (6) independence-performance (performance of the skills required for independent living); (7) employment/occupation (engagement in employment), The sum of each scale, and the full scale is standardized and normalized with a mean of 100 and standard deviation of 15. Higher scores represent better health outcomes.
'Social Isolation' subscale of the Structured Interview for Schizotypy-Revised (SIS-R)
Time frame: Chart review for the legacy data from when participants were first assessed between 2004 and 2015; and Three times daily for 14 days
Social isolation is measured with the 'Social Isolation' subscale of the Structured Interview for Schizotypy-Revised (SIS-R). The subscale range from 0 (virtually no evidence of symptoms) to 6 (symptoms present and quite severe).
3 secondary outcomes
The Revised UCLA Loneliness Scale (R-UCLA)
Time frame: Day 1
Ecological Momentary Assessment (EMA)
Time frame: Chart review legacy data; and 3 times daily for 14 days
Barriers to Access to Care Evaluation scale (BACE)
Time frame: Day 1
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 19 Feb 2026.
- Derived from this study: PubMed 41808086Koster M, van der Pluijm M, Baldwin H, Greenburgh A, King D, Arnold C, Lopez-Morinigo JD, Underwood S, Larrauri CA, Racher M, Glahn DC, Harvey PD, Sandin S, Stevens M, Pearlson G, Arango C, Dazzan P, Morgan C, de Haan L, Reichenberg A, Velthorst E. Social Isolation and Aging health in Schizophrenia spectrum disorders (SIAS): study protocol for a multinational longitudinal study. BMC Psychiatry. 2026 Mar 10;26(1):324. doi: 10.1186/s12888-026-07936-y.
- Individual participant dataSharing planned: Yes. Data from this study available in publications is shared via the NIMH National Data Archives (NDA) and is available in NDA collection C4431.
Related trials for Schizophrenia and Related Disorders
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Not yet recruitingPhase 2
An Investigation of Mechanisms That Underly Paranoia in Behaviour and Brain That Can Inform Clinical Diagnoses That Include Paranoid Symptoms.
None Volunteer
Not yet recruiting
Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
Schizophenia Disorder, Severe Mental Illness
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
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.
Abraham Reichenberg principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Related Disorders, run by Icahn School of Medicine at Mount Sinai at 4 sites in 4 countries.
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 15 inclusion and 0 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands, Spain, United Kingdom. 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 Eva Velthorst, PhD (+31618644345, e.velthorst@ggz-nhn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of newly diagnosed conditions (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419321, which also lists 1 linked publication.
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 19 Feb 2026.