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

8. September 2021 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

400

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Styria
      • Graz, Styria, Österreich, 8036
        • Rekrutierung
        • Medical University Graz
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Nina Dalkner, PhD
        • Unterermittler:
          • Susanne Bengesser, MD, PhD, BSc
        • Hauptermittler:
          • Eva Reininghaus, MD, PhD, MBA

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Study participants with bipolar disorder and healty controls

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PRS of stress or depression
Zeitfenster: 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
Zeitfenster: 3 Years
genetic sum score for COVID-19 infection (polygenic risk score)- the higher the score, the higher the risk
3 Years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2021

Primärer Abschluss (Voraussichtlich)

1. September 2024

Studienabschluss (Voraussichtlich)

30. September 2024

Studienanmeldedaten

Zuerst eingereicht

21. Juli 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juli 2021

Zuerst gepostet (Tatsächlich)

22. Juli 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. September 2021

Zuletzt verifiziert

1. September 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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