The relationship between the month of birth and ADHD treatment

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Descriptive

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA04) methylphenidate

  methylphenidate

  (N06BA02) dexamfetamine

  dexamfetamine

  (N06BA09) atomoxetine

  atomoxetine
• Medical condition to be studied:
  Attention deficit hyperactivity disorder

Population studied

• Short description of the study population:
  The study cohort will include children and adolescents (hereafter referred to as children) ≤ 24 years old who use attention deficit hyperactivity disorder (ADHD) medication for the first time (incident users).
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  Is there a relationship between the month of birth and the pharmacological treatment of ADHD in children and adolescents?
• Outcomes:
  The start of ADHD medication.
• Data analysis plan:
  The analysis will be descriptive. The children receiving ADHD medication with a different month of birth will be compared. The age at which a child receives the treatment for the first time will be defined, it will be represented as the number of months from birth until the first dispensing date. Also the period the children use the ADHD medication will be analysed. The measures of occurrence and association are the incidence rates and the relative risks.Analyses are stratified according to sex, age categories and the calendar year the ADHD medication is dispensed for the first time. We will correct for the total number of births in different months/years.