Longitudinal trends in the use of psychotropic medications in a Spanish pediatric population

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Longitudinal observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000097448

  PSYCHOLEPTICS

  100000097650

  ANTIDEPRESSANTS

  100000097649

  PSYCHOANALEPTICS

Population studied

• Short description of the study population:
  Pediatric population (0-18 years old) who attended Mental Health Care Service during the study period.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  4000

Study design details

• Main study objective:
  The aim of this study is to describe the usage profile and the evolution of psychotropic medication prescription in specialized mental health care among a local paediatric population in Spain between 2013 and 2017.
• Data analysis plan:
  A descriptive analysis will be carried out using the mean, standard deviation, median and range for continuous variables and counts and percentages for categorical variables. For the subgroup analysis, our population is grouped into one of three categories: babies from 0 to 5 years old, babies from 6 to 11 years old and teenagers from 12 to 18 years old. To determine significantly positive or negative trends over time, the trend tests of the Linear Association by Line will be used for variables with more than two categories analyzed.All statistical analyzes will be performed with the statistical software IBM® SPSS (Statistical Package for the Social Sciences), version 18 (IBM® Corporation, Somers, NY, USA).