Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Case-control
Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N06A) ANTIDEPRESSANTS
ANTIDEPRESSANTS

Medical condition to be studied

Depression
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)

Special population of interest

Pregnant women

Estimated number of subjects

6000000
Study design details

Main study objective

To assess the association between in utero exposure to SSRI / SNRIs and neurodevelopmental outcomes and major congenital anomalies

Outcomes

Children with neurodevelopmental outcomes, Children with congenital anomalies

Data analysis plan

Each partner contributing to the study will run centrally produced analysis scripts on their own data, and upload aggregated results or effect estimates to the ConcePTION platform for meta-analyses by the postdoc researcher. Descriptive analysis: categorical variables will be summarized by frequencies and proportions of each modality, including the proportion of missing data. Mean, standard deviation and error, median and interquartile range will be provided for continuous variables. 95% Confidence intervals (CI) will be estimated using Normal approximation for quantitative relevant parameters. Cells with small numbers will be collapsed. We will conduct univariate and multivariate logistic, poisson, or linear regression and Cox proportional hazards regression on the data sources, based on an agreed SAP.