Study identification

EU PAS number

EUPAS36912

Study ID

37083

Official title and acronym

Psychosis and psychotic disorders” and “Depression and suicide/self-injury” following exposure to Hydroxychloroquine and chloroquine

DARWIN EU® study

No

Study countries

Germany

Study description

Hydroxychloroquine (HCQ) and chloroquine (CQ) are nationally authorised 4-aminoquinoline antimalarial agents originally developed as less toxic alternatives to quinine. Both have risen to prominence in the earlier months of 2020 as potential treatments in the current COVID-19 pandemic. In May 2020, the Spanish regulatory Agency (AEMPS) warned about the occurrence of neuropsychiatric reactions associated with intake of HCQ and CQ in patients being treated for COVID-19. This new information let to initiation of a signal procedure at the European Union’s Pharmacovigilance Risk Assessment Committee (PRAC) and led to further review of data pertaining to the association of neuropsychiatric reactions with chloroquine/hydroxychloroquine. Analyses of healthcare records held at the EMA has supported further analyses of data relating to this signal. This study has considered data recorded in the electronic electronic health records database: IMS ® Disease Analyzer Germany (IMS‐Germany). It looks at the risk of “Psychosis and psychotic disorders” and “Depression and suicide/self-injury” following exposure to Hydroxychloroquine and Chloroquine.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Karin Hedenmalm

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable