Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000280

EU PAS number

EUPAS1000000280

Study ID

1000000280

Official title and acronym

DARWIN EU® - Suicidality following exposure to doxycycline

DARWIN EU® study

Yes

Study countries

Netherlands
Spain
United Kingdom

Study description

There have been reports on a potential association between use of doxycycline and suicide. By means of a self-controlled case series and an active comparator cohort study, the study aims to assess the association between use of doxycycline and specific outcomes of interest (i.e. suicidality events).
Research questions
1. Is there an association between the use of doxycycline and suicide-related events?
2. Does the association between doxycycline use and completed suicide and suicide-related events vary by indication of use, compared to active comparators?
Objectives
1. To use a new-user cohort study to assess the association between doxycycline and completed suicide, composite suicide and suicide-related events (completed suicide, suicide ideation and suicide attempt, self-harm), composite suicide-related events (suicide ideation, suicide attempt, self-harm), depression and anxiety, compared to active comparators, stratified by indication of acne vulgaris, rosacea, chlamydia and lower respiratory tract infection (CAP or bronchitis)
2. To use a self-controlled case series study to assess the association between use of doxycycline and composite suicide-related events (including suicide ideation, suicide attempt, self-harm), depression and anxiety.
Research methods
Study design
New-user cohort study with active comparator (objective 1) and self-controlled case series (objective 2)
Population
The study population is new users of doxycycline (SCCS and cohort study) or the comparators (cohort). The new-user cohorts will be per indication: acne vulgaris: doxycycline, erythromycin or isotretinoin; rosacea: doxycycline, erythromycin or isotretinoin; chlamydia: doxycycline, azithromycin, erythromycin or amoxicillin; and lower respiratory tract infection (CAP and bronchitis): doxycycline, azithromycin, or amoxicillin.

Study status

Finalised
Research institution and networks

Institutions

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
English (863.74 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