An observational study in Schizophrenia and Related Disorders, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 4 sites in 4 countries. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 650 is above the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion and exclusion criteria for participants with SZ:
The inclusion and exclusion criteria for sibling participants in this study will be:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with a schizophrenia-related diagnosis
Unaffected first-degree relatives of individuals with a schizophrenia-related diagnosis
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).
Time frame: 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.
Time frame: Day 1
Number of Participants with High Cholesterol
High cholesterol (defined as low-density lipoprotein ≥160 mg/dL or total cholesterol ≥240 mg/dL)
Time frame: Day 1
Number of participants with High Blood Pressure
High blood pressure (defined as systolic ≥130 mm Hg or diastolic ≥80 mm Hg).
Time frame: 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.
Time frame: 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.
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' 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).
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
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.
Time frame: 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
Time frame: 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.
Time frame: Day 1
Plan to share: Yes — Data from this study available in publications is shared via the NIMH National Data Archives (NDA) and is available in NDA collection C4431.
Supporting information: Study protocol, Informed consent form
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