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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33029
• EU PAS number:
  EUPAS33028
• Study ID:
  33029
• Official title and acronym:
  Longitudinal trends in the use of psychotropic medications in a Spanish pediatric population
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Background: An increase in prescription of psychotropic medications in children and adolescents has been reported in some countries. We report the evolution in a Health Area in Spain in the period 2013-2017. Aims:To describe psychopharmacologic prescriptions and the users’ profile in a paediatric population attending a Mental Health Care Service and its evolution between 2013-2017.Methods: a longitudinal observational study will be carried out. All electronic medical records of the pediatric population (0-18 years old) who attended our mental health area during this period will be included. Each year it will be treated as a specific cohort that includes all patients treated during that year to perform a trend analysis during the 5-year period. Demographic data, psychiatric diagnoses and psychotropic prescription will be collected for all patients treated.
• Study status:
  Finalised

Research institution and networks

Institutions

Clinical Pharmacology Service, Puerta de Hierro-Majadahonda University Hospital (HUPHM)

Spain

Study timelines

Date when funding contract was signed

Planned: 01/01/2016

Actual: 01/05/2016

Study start date

Planned: 01/06/2016

Actual: 01/01/2019

Date of final study report

Planned: 01/01/2020

Actual: 01/01/2020

Sources of funding

Other

More details on funding

Clinical Pharmacology Service HUPHM

Study protocol

Initial protocol

Resumen ESTUDIO DE UTILIZACIÓN DE PSICOFARMACOS EN LA POBLACIÓN PEDIATRICA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable