Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N06A) ANTIDEPRESSANTS
ANTIDEPRESSANTS
(N06AB) Selective serotonin reuptake inhibitors
Selective serotonin reuptake inhibitors

Medical condition to be studied

Childhood depression
Pregnancy

Additional medical condition(s)

Antenatal depression, Offspring diagnoses of depression, anxiety, ADHD and autism spectrum disorders
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

242000
Study design details

Main study objective

To investigate the impact of antenatal SSRI exposure on offspring psychiatric disorders into early adulthood in a national birth cohort

Outcomes

Offspring diagnosis of depression. Offspring diagnoses ofAnxiety disorders Autism spectrum disorder (ASD) Attention deficit hyperactivity disorder (ADHD) Tourette syndrome (TS) Speech, motor, and scholastic disorders

Data analysis plan

To determine whether the sharp rise in risk of depression observed in our previous research (defined as register diagnoses of major depressive disorder/other depressive disorders) among maternal SSRI-exposed subjects at 12-14 years of age continues into older age groups, we will first visually examine plots of cumulative incidence functions with confidence bands (based on Kaplan-Meier estimators), then we will fit Cox regression models. We will then add interaction terms for the product of maternal exposure category and age (or a more general function of age, for example, a dichotomous indicator of onset age, treated as a time-dependent covariate) to Cox models. Significant (p<0.05) p-values for these product terms will suggest that the risk of depression associated with prenatal SSRI exposure varies by offspring age. We will estimate separate HRs for the association of maternal SSRI exposure with depression diagnosed before and after the median age of diagnosis.