SSRIs during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06AB) Selective serotonin reuptake inhibitors

  Selective serotonin reuptake inhibitors
• Medical condition to be studied:
  Autism spectrum disorder

  Attention deficit hyperactivity disorder

Population studied

• Short description of the study population:
  Women during pre-pregnancy or pregnancy with or without serotonin re-uptake inhibitor (SSRI) exposure.
• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To undertake a systematic review identifying observational studies evaluating risk of autism spectrum disorder and attention deficit hyperactivity disorder following maternal exposure to selective serotonin re-uptake inhibitors during pregnancy. To assess confounding adjustment within studies and the different effect estimates for different reference groups reported.
• Outcomes:
  ASD and ADHD
• Data analysis plan:
  To describe the type of studies, their characteristics and the variables used for confounding adjustment by them. To describe the types of comparator groups used to compare risk from SSRI exposure with a focus on:maternal exposure during pregnancy compared to all unexposed women, maternal exposure during the pre-pregancy period compared to all unexposed women, maternal exposure during pregnancy compared to all unexposed women with an affective disorder, paternal exposure during pregnancy, and sibling designs. To explore the effect of meta-analysis for different exposures using generic inverse variance method of analysis in Review Manager.