An observational study in Fibromyalgia (FM) and Depression, sponsored by Sergio Gabriel Susmallian. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Sergio Gabriel Susmallian · Observational
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and difficulties with daily activities. Many people with fibromyalgia also experience psychiatric disorders, particularly depression and anxiety. However, the relationship between these conditions and long-term disability remains incompletely understood.
This nationwide study examines the relationship between fibromyalgia, psychiatric disorders, and disability among individuals whose claims were evaluated by the Israeli National Insurance system between 2018 and 2025.
The study compares two groups: individuals assessed through the general disability system and those assessed through the occupational injury system. It investigates differences between women and men, psychiatric comorbidity, assigned disability severity, temporary and permanent disability, and changes over time.
The research uses existing anonymized administrative records. No experimental treatment, additional examinations, or direct patient participation is required.
The findings may help improve understanding of psychiatric comorbidity in fibromyalgia and support more comprehensive clinical and occupational disability assessments.
This nationwide retrospective observational study analyzes administrative data from the National Insurance Institute of Israel covering January 1, 2018, through December 31, 2025.
The investigation focuses on the association between fibromyalgia, documented psychiatric disorders, particularly depressive-spectrum conditions, and disability-related outcomes in two independent administrative systems: general disability and recognized occupational injury.
Fibromyalgia-related claims are identified through recorded clinical diagnostic classifications. Psychiatric comorbidity is evaluated using the documented diagnostic information for individual claimants. Analyses are stratified by disability system, sex, and age.
The investigation distinguishes primary claims, individual claimants, impairment assessments, and disability determinations to account for differences between administrative datasets. Assigned disability severity is evaluated using assessment-weighted impairment percentages, while disability outcomes are classified according to permanence and temporary-disability duration.
Statistical analyses include Pearson's chi-square tests, risk ratios with 95% confidence intervals, comparisons of mean ages, and sex standardization. Temporal changes in fibromyalgia-related claim frequencies are examined using Poisson regression with robust standard errors and negative binomial sensitivity analysis.
The study evaluates associations rather than causal relationships. In particular, administrative recognition of occupational injury does not establish that an occupational event caused fibromyalgia or a psychiatric disorder.
The study involves retrospective analysis of existing de-identified information without clinical intervention, additional procedures, or direct contact with patients.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's enrollment of 56,716 is above the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Sergio Gabriel Susmallian is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population comprised individuals with primary fibromyalgia-related disability claims recorded in the National Insurance Institute of Israel between January 1, 2018, and December 31, 2025. Data were obtained from two national administrative systems: general disability and occupational injury. Eligible claimants were classified according to the presence or absence of a documented concomitant psychiatric disorder in the same individual. Demographic characteristics, disability severity, impairment percentages, and temporary or permanent disability determinations were evaluated. The study was nationwide, retrospective, and observational, using anonymized administrative records. No participants were prospectively recruited, and no interventions were performed.
Exclusion Criteria: -Individuals without a documented fibromyalgia diagnosis.
individuals that claim for fibromyalgia
Individual that claim for both conditions
Proportion of Fibromyalgia Patients With Documented Psychiatric Comorbidity
Percentage of patients with fibromyalgia who also have a documented psychiatric disorder, particularly a depressive-spectrum disorder. Psychiatric comorbidity is defined by the presence of both diagnoses in the same individual. The proportion will be compared between general disability and occupational injury systems and stratified by sex.
Time frame: January 1, 2018, to December 31, 2025
Plan to share: No — Individual participant data will not be publicly shared because the study uses confidential national administrative records containing sensitive medical, demographic, and disability-related information. Although the data were anonymized for research purposes, public disclosure could create a risk of participant re-identification. Data access is subject to institutional authorization and ethical restrictions. Aggregated, non-identifiable study results will be available through scientific publication.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Sergio Gabriel Susmallian