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Social Isolation and Aging in Schizophrenia

Sponsor: Icahn School of Medicine at Mount Sinai

NCT ID: NCT07419321

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 42 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at social isolation and ageing in people with schizophrenia and related disorders. It is run by the Icahn School of Medicine at Mount Sinai. People who took part in an earlier study may be invited back for further checks.

Who can take part

  • A diagnosis of a schizophrenia-related disorder (for example schizophrenia or schizoaffective disorder) based on a clinical interview
  • Aged between 40 and 70 when joining the study
  • Took part in a previous research study between the ages of 20 and 55, with that study at least 5 years ago
  • Able to understand the spoken language of the country where the study takes place well enough to follow the tests
  • Clinically stable — no hospital stays for the past three months and no medication changes in the four weeks before joining
  • Healthy siblings may also take part if they meet similar age, previous study, language, and stability rules

Who may not be able to

  • A history of serious head injury (being unconscious for more than 1 hour, lasting effects, or rehabilitation treatment after the injury)
  • A history of intelligence quotient (IQ) below 70 or a developmental disability, based on medical record checks
  • A psychotic disorder caused only by substance use
  • For siblings: any past diagnosis known to affect social functioning, such as a severe mood disorder or autism spectrum disorder

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
40 Years to 70 Years
Who
All
Number of participants
650
Started
2024-01-09
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for schizophrenia and related disorders
  • • Clinical study - 650 participants
  • • 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

Who can take part?

  • • Ages 40 Years to 70 Years
  • • Diagnosed with schizophrenia and related disorders

Where?

  • • London - King's College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Schizophrenia and Related Disorders

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 70 Years
  • Who can join: All genders

What the study is looking for

  • ✓Inclusion and exclusion criteria for participants with SZ:
  • ✓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...
  • ✓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,...
See the full criteria
Inclusion and exclusion criteria for participants with SZ: * 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; * 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

Where Is This Study? (1 UK site)

King's College London

London Se58AF, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Eva Velthorst, PhD

Sponsor contact

CONTACT

+31618644345 e.velthorst@ggz-nhn.nl
Data sourced from ClinicalTrials.gov · Last verified: 2026-02