Genetics of COVID-19 Risks & Resilience in Bipolar Disorder
NCT ID: NCT04972708
Last Updated: 2021-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2021-07-01
2024-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bipolar Disorder
100 patients after COVID-19 infection 100 patients without COVID-19 infection
Cross-sectional genetics study
Cross-sectional genetics study
Healthy controls
100 controls after COVID-19 infection 100 controls without COVID-19 infection
Cross-sectional genetics study
Cross-sectional genetics study
Interventions
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Cross-sectional genetics study
Cross-sectional genetics study
Eligibility Criteria
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Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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Medical University Graz
Graz, Styria, Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-199 ex 10/11
Identifier Type: -
Identifier Source: org_study_id
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