NCT04972708

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

July 21, 2021

Last Update Submit

September 8, 2021

Conditions

Bipolar DisorderCovid19Stress

Keywords

bipolar disordercovid-19 pandemic

Outcome Measures

Primary Outcomes (2)

  • PRS of stress or depression

    genetic sum score for depression (polygenic risk score)- the higher the score, the higher the risk

    3 Years

  • PRS of COVID-19 infection

    genetic sum score for COVID-19 infection (polygenic risk score)- the higher the score, the higher the risk

    3 Years

Study Arms (2)

Bipolar Disorder

100 patients after COVID-19 infection 100 patients without COVID-19 infection

Genetic: Cross-sectional genetics study

Healthy controls

100 controls after COVID-19 infection 100 controls without COVID-19 infection

Genetic: Cross-sectional genetics study

Interventions

Cross-sectional genetics studyGENETIC

Cross-sectional genetics study

Bipolar DisorderHealthy controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study participants with bipolar disorder and healty controls

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8036, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood

MeSH Terms

Conditions

Bipolar DisorderCOVID-19

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Eva Reininghaus, MD, PhD, MBA

CONTACT

+43 316 385 80968eva.reininghaus@medunigraz.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 22, 2021

Study Start

July 1, 2021

Primary Completion

September 1, 2024

Study Completion

September 30, 2024

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)