USE OF PSYCHOTROPIC DRUGS IN CHILDREN AND ADOLESCENTS IN CATALONIA. A cohort study with real world data from the electronic primary health care record from 2007-2017. (PEPSICAT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA) Centrally acting sympathomimetics

  Centrally acting sympathomimetics

  (N06A) ANTIDEPRESSANTS

  ANTIDEPRESSANTS

  (N05A) ANTIPSYCHOTICS

  ANTIPSYCHOTICS

  (N05B) ANXIOLYTICS

  ANXIOLYTICS

  (N05C) HYPNOTICS AND SEDATIVES

  HYPNOTICS AND SEDATIVES
• Medical condition to be studied:
  Psychiatric investigation

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • 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:
  300000

Study design details

• Main study objective:
  To describe the use of psychotropic drugs in children <18 years from Catalonia during 2007-2017.To describe the psychiatric diagnoses in the <18 years population consuming psychotropic drugs.To describe the consumption pattern and characteristics of patients <18 years who start treatment with psychotropic drugs.
• Data analysis plan:
  All data management, purification, descriptive calculation and statistical analysis processes will be carried out using the statistical package R 3.3(2016)Demographic data and baseline characteristics of the population will be described by relative and absolute frequencies for the categorical variables and median standard deviation or median and interquartile range for the continuous variables.In the bivariate analysis, Chi-square test or the exact Fischer test for the categorical variables and the t-test of Student or the U-test of Mann-Whitney for the continuous variables according to their distributionEvaluation of psychotropic consumption based on psychiatric/obstetric maternal records, as well as the risk related to the persistence/adherence of these in patients with an age range of 16 to 18 years old, will be performed using multiple logistic regression models or proportional risk models (Cox).Adjustment for risk factors based on the characteristics of the study population