Study identification

PURI

https://redirect.ema.europa.eu/resource/39974

EU PAS number

EUPAS37790

Study ID

39974

Official title and acronym

The effect of mental disorders and treatment with psychotropic agents on the course of COVID-19 (COVID-19 psychotropics)

DARWIN EU® study

No

Study countries

Denmark

Study description

Beyond the psycho-social consequences of the coronavirus disease 2019 (COVID-19) pandemic, people with severe mental disorders, such as schizophrenia and bipolar disorder have been reported with an up to 2-fold increased 30-days risk of death after a severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) positive test. Recent use of psychotropic agents has also been associated with increased risk of death, varying between 50% in users of antidepressants to a three-fold increase in users of antipsychotics. The importance of maintaining and adjusting pharmacological treatment of people with severe mental disorders during the COVID-19 pandemic has been emphasized. Identifying those drugs with lower risk profiles regarding adverse outcomes to COVID-19 will support guidance of selecting and adjusting acute and maintenance treatment during the COVID-19 pandemic. The present study aims at providing a population-based description of the association and potential differential impact of frequently used psychotropic drugs on the course and outcomes of COVID-19 in people with hospital diagnosed and without hospital diagnosed psychiatric disorders. We hypothesize that psychotropic treatment patterns differ between community-treated COVID-19 patients and hospitalized or deceased COVID-19 patients with lower risks for unfavourable outcomes in users of a) aripiprazole, haloperidol, risperidone or paliperidone as oral or short-acting injectable antipsychotics vs. other oral or depot long-acting antipsychotics, b) short-acting benzodiazepines vs. long-acting benzodiazepines, c) SSRIs vs. tricyclic antidepressants. We will use data from the prospectively collected Danish COVID-19 cohort at Statens Serum Institut including all Danish residents tested by the reverse transcriptase polymerase chain reactions (RT-PCR) for SARS-CoV-2.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Christiane Gasse

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

SSI, AU-ADA Pro bono
Study protocol
Initial protocol

Protocol_COVID 19 mental disorders_20200924_corr_ENCEPP_signed

English (899.94 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable