Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Genetics of COVID-19 Risks & Resilience in Bipolar Disorder (BIPCOVID)

8. september 2021 opdateret af: Medical University of Graz

Genetics of COVID-19 Risks & Resilience in Bipolar Disorder as Subproject of BIPGEN (Genetic Changes in Bipolar Disorder)

BIPGEN is a cross-sectional study on the genetics of bipolar disorder. As a subproject of BIPGEN, BIP-COVID is a cross-sectional genetics study about risks & resilience in the COVID-19 (Coronavirus disease) pandemic in bipolar disorder (BD) and healthy controls at the Medical University of Graz. Study participants with BD and controls from the well-established BIPLONG and BIPGEN studies will undergo a special BIP-COVID visit, which will include a COVID-19 specific online Lime survey about the psychological burden in the COVID-19 crisis, a COVID-19 antibody test (IgM and IgG), inflammation markers and isolation of DNA from fasting blood. Genotyping of DNA will be done with the GSA V.3 array. Genetic analyses (Polygenic Risk Scores of I. Stress or Major Depression and II. COVID-19 infection established with the programs PLINK, PRSice and R) will be used to analyze the genetic mechanisms of COVID-19 pandemic associated psychological symptoms and COVID-19 infection risk. Systems biology methods will be used to depict protective pathways against COVID-19 infection (e.g. Lithium pathways) and against COVID-19 associated psychiatric symptoms.

Studieoversigt

Status

Rekruttering

Detaljeret beskrivelse

Methods: BIPGEN is a cross-sectional study on the genetics of bipolar disorder (BD). BIPGEN includes a personality questionnaire (TEMPS-A). DNA is isolated in the BIPGEN study from fasting blood with the QUIASYMPHONY robot from study participants with Bipolar Disorder (diagnosis according to DSM-IV) and healthy controls. The DNA is then genotyped with classic genotyping arrays (GWAS array). The aim of BIPGEN is to associate genetic variants (single-nucleotide-polymorphisms/ SNPs or copy-number-variations/CNVs) with bipolar affective disorder.

A subproject of BIPGEN is the BIP-COVID project, which is a cross-sectional genetics study about risks & resilience in the COVID-19 pandemic in BD and healthy controls at the Medical University of Graz. Study participants with BD and controls from the well-established BIPLONG and BIPGEN studies will undergo a special BIP-COVID visit, which will include a COVID-19 specific online Lime survey about the psychological burden in the COVID-19 crisis, a COVID-19 antibody test (IgM and IgG), inflammation markers and isolation of DNA from fasting blood. Genotyping of DNA will be done with the GSA V.3 array. Genetic analyses (Polygenic Risk Scores of I. Stress or Major Depression and II. COVID-19 infection established with the programs PLINK, PRSice and R) will be used to analyze the genetic mechanisms of COVID-19 pandemic associated psychological symptoms and COVID-19 infection risk. Systems biology methods will be used to depict protective pathways against COVID-19 infection (e.g. Lithium pathways) and against COVID-19 associated psychiatric symptoms

Aim:

  1. We aim at analyzing the neuropsychological and genetic underpinning of COVID-19 associatedreactive psychiatric symptoms in BD and in healthy controls.
  2. We aim at analyzing genetic predictors of COVID-19 infection in BD and in controls.
  3. We aim at analyzing the protective effects of the GSK-3β inhibitor lithium against COVID-19 infection.

Intervention: Cross-sectional genetics study

Key inclusion and exclusion criteria: Inclusion criteria are written consent after previous written and verbal information, diagnosis of BD according to DSM-IV and age between 18 and 75 years. Exclusion criteria include acute suicidality, lack of consent, severe active drug dependence (i.e., alcohol, benzodiazepines, morphine), other currently active severe mental / cerebral organic disease (e.g. epilepsy, brain tumor), severe skull-brain trauma / brain surgery in the past, known florid tumor disease, congenital / infantile mental retardation, dementia (from Mini-Mental State Examination (MMSE) 20), severe florid autoimmune diseases or current immunosuppression (e.g., lupus erythematosus, HIV (human immunodeficiency virus), multiple sclerosis), cardiac, renal and pulmonary disorders or PTSD (post-traumatic stress disorder) or anxiety.

Healthy controls do not have a history of mental disorder and do not have first- or second-degree relatives with psychiatric disorders.

Primary and secondary endpoint(s) of the BIPCOVID project:

The primary endpoint is PRS of stress, the secondary endpoint is PRS of COVID-19 risk.

Sample size, statistical analyses, power calculation: The program G*Power (Version 3.1) was used for the calculation of the number of cases. Linear bivariate regression analyses for two groups (BD and control cohort) will be calculated with the results from psychological/psychiatric inventories as predictors (e.g. Pittsburgh Sleep Quality Index, Mediterranean Diet Score, Resilience Scale) and the three PRS as criterion. G*Power calculates for a linear bivariate regression, with a Δ slope of 0.03, α = .05 and a power of 95 % a total sample size of 364 persons.

Trial duration of BIPCOVID: 3 years.

Participating centers: The BIP-COVID sample will be recruited as monocentric study at the special outpatient department for Bipolar Disorders (managed by Univ.Prof. Eva Reininghaus) at the Department of Psychiatry and Psychotherapeutic Medicine at the Medical University of Graz, Austria. Psychiatric genetics and bioinformatics experts from the University of Basel, the University of Marburg, the University of Bonn, the Karolinska Institutet & Medical University of Vienna & CAMH Toronto will supervise the KLIF-funded doctoral student and will support the state-of-the-art bioinformatics analyses.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Styria
      • Graz, Styria, Østrig, 8036
        • Rekruttering
        • Medical University Graz
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Nina Dalkner, PhD
        • Underforsker:
          • Susanne Bengesser, MD, PhD, BSc
        • Ledende efterforsker:
          • Eva Reininghaus, MD, PhD, MBA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Study participants with bipolar disorder and healty controls

Beskrivelse

Inclusion Criteria:

  • Inclusion criteria are written consent after previous written and verbal information, diagnosis of BD according to DSM-IV and age between 18 and 75 years.

Exclusion Criteria:

Exclusion criteria include

  • acute suicidality
  • lack of consent
  • severe active drug dependence (i.e., alcohol, benzodiazepines, morphine)
  • other currently active severe mental / cerebral organic disease (e.g. epilepsy, brain tumor),
  • severe skull-brain trauma / brain surgery in the past,
  • known florid tumor disease,
  • congenital / infantile mental retardation,
  • dementia (from MMSE 20),
  • severe florid autoimmune diseases or current immunosuppression (e.g., lupus erythematosus, HIV, multiple sclerosis),
  • cardiac, renal and pulmonary disorders or PTSD or anxiety
  • Healthy controls do not have a history of mental disorder and do not have first- or second-degree relatives with psychiatric disorders.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Bipolar Disorder
100 patients after COVID-19 infection 100 patients without COVID-19 infection
Cross-sectional genetics study
Healthy controls
100 controls after COVID-19 infection 100 controls without COVID-19 infection
Cross-sectional genetics study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PRS of stress or depression
Tidsramme: 3 Years
genetic sum score for depression (polygenic risk score)- the higher the score, the higher the risk
3 Years
PRS of COVID-19 infection
Tidsramme: 3 Years
genetic sum score for COVID-19 infection (polygenic risk score)- the higher the score, the higher the risk
3 Years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2021

Primær færdiggørelse (Forventet)

1. september 2024

Studieafslutning (Forventet)

30. september 2024

Datoer for studieregistrering

Først indsendt

21. juli 2021

Først indsendt, der opfyldte QC-kriterier

21. juli 2021

Først opslået (Faktiske)

22. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner