Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Prescription event monitoring
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N05A) ANTIPSYCHOTICS
ANTIPSYCHOTICS
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)

Estimated number of subjects

250
Study design details

Main study objective

The principal objective of this clinical program is to guarantee a safe use of antipsychotics in children and adolescents through early prevention and detection of adverse events and pharmacological interactions of antipsychotic treatment in pediatric populations. Moreover, close monitoring and long-term follow-up also aims to enhance treatment adherence as well as patient and family alliance.

Outcomes

The potential adverse effects were closely monitored during each office visit using the Safety Monitoring Uniform Report Form. Symptoms related to neurological adverse effects are explored with Sympson-Angus Akatisia Scale (SAS) and Abnormal Involuntary Movement Scale (AIMS). -Sociodemographic, diagnostic and therapeutic characteristics -Personal medical and psychiatric history-Healthy lifestyle habits-Pharmacological history-Monitoring of therapeutic compliance using a questionnaire prepared ad hoc.-Evaluation of clinical data:CBCL, MiniKID, ASSQ, CGAS and CGI)-Physical examination and electrocardiogram-Biological parameters

Data analysis plan

Risk estimation
Documents
Study publications
Palanca-Maresca I, Ruiz-Antorán B, Centeno-Soto GA, Forti-Buratti MA, Siles A, …
Palanca-Maresca I, Ruiz-Antorán B, Centeno-Soto G, Jiménez-Fernandez S, García-…