Status: Finalised First registered on: 08/01/2020
Last updated on: 08/01/2020
1. Study identification
EU PAS Register NumberEUPAS33028
Official titleLongitudinal trends in the use of psychotropic medications in a Spanish pediatric population
Study title acronym
Study typeObservational study
Brief description of the studyBackground: 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsClinical Pharmacology Service HUPHM
Department/Research groupClinical Pharmacology Service
Organisation/affiliationPuerta de Hierro-Majadahonda University Hospital
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name Ruiz-Antoran
First name Belen
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201601/05/2016
Start date of data collection01/06/201601/01/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report01/01/202001/01/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherClinical Pharmacology Service HUPHM100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ruiz-Antoran
First name Belen
Address line 1Manuel de Falla 1.
Address line 2 
Address line 3 
CityMadrid 
Postcode28222 
CountrySpain
Phone number (incl. country code)0034911916481 
Alternative phone number 
Fax number (incl. country code) 
Email address bruiz.hpth@salud.madrid.org
Public Enquiries
Title Dr 
Last name Ruiz-Antoran 
First name Belen 
Address line 1Manuel de Falla 1. 
Address line 2 
Address line 3 
CityMadrid 
Postcode28222 
CountrySpain 
Phone number (incl. country code)0034911916481 
Alternative phone number 
Fax number (incl. country code) 
Email address bruiz.hpth@salud.madrid.org 
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