- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05293899
The Pathogenesis of Depression - Possible Autoimmune Mechanisms
It has long been claimed that depression, and other psychiatric illness, might be a manifestation of immune dysregulation involving the Central nervous system. Depression is associated with a significantly increased risk of autoimmune disease compared to those without a history of depression. The increased risk of autoimmune diseases is during the first year following the onset of depression .Conversely, up to 50% of patients with autoimmune diseases show an impairment of health-related quality of life and exhibit depressive symptoms.
The aggregation of depression and some specific autoimmune diseases may demonstrate shared inherited pathogenesis.
The first phase of the study will include patients with the diagnosis of depression. The control group will consist of a healthy population, according to medical records and will be recruited through a recruitment ad and volunteers. In the second phase of the study first and second-degree relatives (parents, siblings, children, grandparents, aunts, uncles and cousins) who are diagnosed with autoimmune disease/s will be recruited. Auto-immune diseases will include - Rheumatoid Arthritis (RA), juvenile idiopathic arthritis JIA), Seronegative spondyloarthropathies (SPA) including inflammatory bowel disease (IBD), psoriatic arthritis (PsA), and ankylosing spondylitis. Other autoimmune diseases: Systemic Lupus Erythematosus, Sjogren' syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IIM), any Overlap of the above including mixed connective tissue disease (MCTD), systemic vasculitis (see Chapel Hill classification criteria). All autoimmune diseases will be confirmed by an expert rheumatologist or an internist. Celiac disease, Diabetes Mellitus type I, autoimmune thyroiditis, autoimmune hepatitis will be confirmed by a gastroenterologist, endocrinologist or an internist.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
Afula, Israel, 1910500
- Rekruttering
- Haemek Medical Center
-
Ta kontakt med:
- Gilat Ron Avraham
- Telefonnummer: 0528495336
- E-post: gilataavraham@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients must meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria for a diagnosis of depression.
- Sufficient knowledge of the Hebrew language
- A stabled mental state. If hospitalized, patients are scheduled for discharge based on clinical assessment of psychiatric symptoms.
Exclusion Criteria:
- Mental co-morbidity.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1. Find genetic association or genetic basis to depression associated with autoimmune diseases
Tidsramme: 1 day
|
1. Find genetic association or genetic basis to depression associated with autoimmune diseases
|
1 day
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 143-19EMC
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .