Study identification

PURI

https://redirect.ema.europa.eu/resource/26719

EU PAS number

EUPAS3264

Study ID

26719

Official title and acronym

Program for safe use of antipsychotics in pediatric population. Online Spanish safety registry for Neuroleptic treatment in children and adolescents (SENTIA)

DARWIN EU® study

No

Study countries

Spain

Study description

The basic methodology of SENTIA is the creation of an extended online database platform which permits a registry of collected data in relation to short-medium-and long-term safety of antipsychotics in children and adolescents.This online application makes multicenter participation possible, and has enormous potential for further study of the safety of antipsychotic drugs in the pediatric population.SENTIA is an online registry (https://sentia.es).It is centered in the Child and Adolescent Psychiatry Unit and the Clinical Pharmacology Department of Puerta de Hierro- Hospital and forms part of the “Program for safe treatment with antipsychotics in children and adolescents”. Its objectives are the prevention and early detection of adverse events of these drugs in this population.Children and adolescents, regardless of the diagnosis or clinical symptoms that motivate the prescription, currently under treatment or who are going to initiate treatment with antipsychotics either as monotherapy or combination therapy, are monitored regularly at periods of 1 and 3 months after the initial dose or change of antipsychotic medicine and subsequently, every 6 months for an unlimited period of time. Those who accept to be included in the online Registry are inscribed after completing the Informed Consent.The gathered information is structured as follows: 1-Sociodemographic data,2- Personal medical and psychiatric history and that of immediate family members (related to very common/serious AE),3-Clinical assessment: Achenbach Child Behaviour Checklist (CBCL), Mini International Neuropsychiatric Interview (MiniKID), Children’s Global Assessment Scale (CGAS), Clinical Global Impression (CGI),4- Pharmacological history, 5- Therapeutic compliance (Questionnaire prepared ad hoc), 6- Health habits (Diet, Physical exercise, Toxics), 7- Side effects (AIMS, SAS, SMURF),8- Physical examination and 9-Biological parameters.

Study status

Ongoing
Research institutions and networks

Institutions

Child & Adolescent Psychiatry Unit and the Clinical Pharmacology Service
Basurto Hospital Bilbao. Spain

Contact details

Belen Ruiz Antoran

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Ministry of Health, Social Services and Equality, Mutua Madrileña Foundation
Study protocol
Initial protocol

PROTOCOLO PROYECTO REGISTRO RAM USO ANTIPSICOTICOS PEDIATRIA

English (117.68 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable