Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000294

EU PAS number

EUPAS1000000294

Study ID

1000000294

Official title and acronym

DARWIN EU® - Incidence of suicidality in patients with specific chronic skin conditions

DARWIN EU® study

Yes

Study countries

Croatia
Netherlands
Spain
United Kingdom

Study description

Chronic skin conditions like acne and psoriasis cause significant physical and psychological distress, leading to social stigmatization and an increased risk of mental health issues, including depression and anxiety. Concerns about their link to suicidality-related events are rising. Several signals of suicidal ideation associated with treatments for acne and/or other skin disorders have been discussed. For these signals, it is difficult to estimate the extent of the confounding by indication as the underlying patient population is widely believed to be at increased risk of suicide related conditions. Despite this, there is insufficient data in the literature regarding the background rates of such outcomes in these populations and most studies focusing on broader mental health outcomes. This study aims to evaluate suicide-related drug safety signals associated with treatments for the conditions of acne and psoriasis. Understanding of the background rate of suicidality in patients with these conditions and the extent to which this differs from the general population will aid in the assessment of such signals.
Research questions
What are the background incidence rates of suicidality-related events (completed suicide, attempted suicide, suicidal ideation, and intentional self-harm) in patients with acne and psoriasis and in the general population, overall and stratified by sex, age categories, and by calendar year? Results will further be stratified in individuals with and individuals without a medical history of mental health disorders at start of follow-up.

Outcomes of interest are i) completed suicide, ii) attempted suicide, iii) suicide ideation or iv) intentional self-harm, v) suicide-related events (i.e. completed suicide, attempted suicide, and suicidal ideation), vi) composite outcomes (combination of all above mentioned events).

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Katia Verhamme

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
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-010_Suicidality and skin conditions_V3.pdf

English (842.83 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable