Genetics of COVID-19 Risks & Resilience in Bipolar Disorder (BIPCOVID)
Genetics of COVID-19 Risks & Resilience in Bipolar Disorder as Subproject of BIPGEN (Genetic Changes in Bipolar Disorder)
調査の概要
詳細な説明
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:
- We aim at analyzing the neuropsychological and genetic underpinning of COVID-19 associatedreactive psychiatric symptoms in BD and in healthy controls.
- We aim at analyzing genetic predictors of COVID-19 infection in BD and in controls.
- 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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Eva Reininghaus, MD, PhD, MBA
- 電話番号:+43 316 385 80968
- メール:eva.reininghaus@medunigraz.at
研究場所
-
-
Styria
-
Graz、Styria、オーストリア、8036
- 募集
- Medical University Graz
-
コンタクト:
- Eva Reininghaus, MD, PhD, MBA
- 電話番号:+43 316 385 80968
- メール:eva.reininghaus@medunigraz.at
-
コンタクト:
- Susanne Bengesser, MD, PhD, BSc
- 電話番号:+43 316 385 86224
- メール:susanne.bengesser@medunigraz.at
-
副調査官:
- Nina Dalkner, PhD
-
副調査官:
- Susanne Bengesser, MD, PhD, BSc
-
主任研究者:
- Eva Reininghaus, MD, PhD, MBA
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PRS of stress or depression
時間枠: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
時間枠:3 Years
|
genetic sum score for COVID-19 infection (polygenic risk score)- the higher the score, the higher the risk
|
3 Years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 23-199 ex 10/11
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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