Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Case-control
Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

DOXYCYCLINE

Anatomical Therapeutic Chemical (ATC) code

(J01AA02) doxycycline

Medical condition to be studied

Suicidal behaviour
Suicidal ideation
Suicide attempt
Suicide threat
Completed suicide
Depression suicidal
Depression
Anxiety
Population studied

Short description of the study 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 design details

Study design

New-user cohort study with active comparator (objective 1) and self-controlled case series (objective 2)

Main study objective

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.