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

8 de septiembre de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Anticipado)

400

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Styria
      • Graz, Styria, Austria, 8036
        • Reclutamiento
        • Medical University Graz
        • Contacto:
        • Contacto:
        • Sub-Investigador:
          • Nina Dalkner, PhD
        • Sub-Investigador:
          • Susanne Bengesser, MD, PhD, BSc
        • Investigador principal:
          • Eva Reininghaus, MD, PhD, MBA

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Study participants with bipolar disorder and healty controls

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PRS of stress or depression
Periodo de tiempo: 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
Periodo de tiempo: 3 Years
genetic sum score for COVID-19 infection (polygenic risk score)- the higher the score, the higher the risk
3 Years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2021

Finalización primaria (Anticipado)

1 de septiembre de 2024

Finalización del estudio (Anticipado)

30 de septiembre de 2024

Fechas de registro del estudio

Enviado por primera vez

21 de julio de 2021

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2021

Publicado por primera vez (Actual)

22 de julio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

8 de septiembre de 2021

Última verificación

1 de septiembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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