Study identification

EU PAS number

EUPAS1000000592

Study ID

1000000592

Official title and acronym

DARWIN EU® - Antipsychotic prescribing in children in Europe: a descriptive analysis of trends and patient characteristics

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Germany
Netherlands
Norway
Spain

Study description

Antipsychotic drugs are indicated for the management of schizophrenia and bipolar disorder.
They are also used in adults to manage behavioral and psychological symptoms of dementia (BPSD) with the recommendation to be discontinued after BPSD symptoms resolve.
Antipsychotic drugs can be classified into typical and atypical antipsychotics with different recommendations for their use.
For example, guidelines recommend the preferential use of atypical antipsychotic in adults when required for the management of BPSD.
Safety concerns have previously led to regulatory warnings and risk communications over their use.
Antipsychotic drugs have been associated with several adverse drug reactions, particularly in the elderly. Somnolence, hypotension, extrapyramidal side effects and gait abnormalities are well-recognized side effects that may in turn contribute to the risk of falls and fracture in elderly persons.[1] Similarly, cardiovascular adverse effects, falls and injuries may increase mortality.
Antipsychotics are sometimes used in children and adolescents; however, not all antipsychotics have been approved for use in children and adolescents and if prescribed their use would be considered off-label.
A prior study reported an increased use of antipsychotics between 2008 and 2017 in the paediatric populations of Catalonia (35.7%), Norway (45.1%) and Sweeden (57.6%).
Likewise, in England, the use of antipsychotics in patients between 3 and 18 years doubled between 2000 and 2019.
This study aims to provide an overview of antipsychotic prescribing in children from databases in Europe, and to describe the characteristics of children initiating antipsychotics.
This will provide a benchmark to understand current clinical practice over their use in children and adolescents and help to understand whether off-label use may occur.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marta Pineda Moncusi

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
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