Recruiting

Social Isolation in SZ

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07419321

Conditions

Schizophrenia and Related Disorders

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Study Details

Brief 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. 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

Conditions

Schizophrenia and Related Disorders

Study ID

NCT07419321

Start date

Jan 9, 2024

Status verified date

Feb, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals with SZ

Individuals with a schizophrenia-related diagnosis

Unaffected first-degree relatives

Unaffected first-degree relatives of individuals with a schizophrenia-related diagnosis

Primary outcome measure

  • Occurrence of newly diagnosed conditions [ Time Frame: Day 1 ]
  • Short Form Health Survey (SF-36), [ Time Frame: Day 1 ]
  • Number of Participants with High Cholesterol [ Time Frame: Day 1 ]
  • Number of participants with High Blood Pressure [ Time Frame: Day 1 ]
  • Schedule for Deficit Syndrome (SDS) [ Time Frame: Chart Review for the legacy data from when participants were first assessed between 2004 and 2015 ]
  • 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' 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 ]

Central Contacts and Locations

Central contacts

Locations

Olin Neuropsychiatry Research Center, Hartfort

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • schizophrenia
  • psychosis
  • social isolation
  • physical health
  • longitudinal trajectory
  • siblings

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-19.