SENTIA: a systematic online monitoring registry for children and adolescents treated with antipsychotics

Abstract

IntroductionDespite drastic increases in antipsychotic prescribing in youth, data are still limited regarding their safety in this vulnerable population, necessitating additional tools for capturing long-term, real world data.MethodsWe present SENTIA (SafEty of NeurolepTics in Infancy and Adolescence; https://SENTIA.es), an online registry created in 2010 to track antipsychotic adverse effects in Spanish youth <18 years old currently taking or initiating with any antipsychotic treatment. SENTIA collects information on sociodemographic, diagnostic and treatment characteristics, past personal medical/psychiatric history, healthy lifestyle habits and treatment adherence. Additionally, efficacy and adverse effect data are recorded including the Children’s Global Assessment Scale; Clinical Global Impressions scale for Severity and Improvement, the Safety Monitoring Uniform Report Form, Simpson-Angus Scale, Abnormal Involuntary Movement Scale, vital signs, blood pressure, and EKG. Finally, fasting blood is drawn for hematology, electrolytes, renal, liver and thyroid function, glucose, insulin, lipid, prolactin and sex hormone levels. Initially, a diagnostic interview and several psychopathology scales were also included. Patients are assessed regularly and followed even beyond stopping antipsychotics.ResultsSince 01/17/2011, 85 youth (11.5 ± 2.9 (range = 4-17) years old, 70.6% male) have been included at one inaugural center. After a mean duration of 17 ± 11 (range = 1-34) months, 78.8% are still actively followed. For feasibility reasons, the diagnostic interview and detailed psychopathology scales were dropped. The remaining data can be entered in <30 minutes. Several additional centers are currently being added to SENTIA.ConclusionsImplementation of a systematic online pharmacovigilance system for antipsychotic adverse effects in youth is feasible and promises to generate important information.

Enhancing metabolic monitoring for children and adolescents using second‐generation antipsychotics

“…The Safety of Neuroleptics in Infancy and Adolescence (SENTIA) online registry was launched in 2010 by the Clinical Program for Safe Antipsychotic Use in Children and Adolescents at a hospital in Madrid (Palanca-Maresca et al 2014). The Safety of Neuroleptics in Infancy and Adolescence (SENTIA) online registry was launched in 2010 by the Clinical Program for Safe Antipsychotic Use in Children and Adolescents at a hospital in Madrid (Palanca-Maresca et al 2014).…”

“…Novel technologies such as the national electronic databases devoted to documenting metabolic monitoring practices may be part of the solution. The Safety of Neuroleptics in Infancy and Adolescence (SENTIA) online registry was launched in 2010 by the Clinical Program for Safe Antipsychotic Use in Children and Adolescents at a hospital in Madrid (Palanca-Maresca et al 2014). SENTIA is an online pharmacovigilance software platform used to facilitate systematic monitoring of antipsychotic and reporting of adverse events.…”

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

“…Use of antipsychotics was higher in our sample than in other studies (2) (3) (4) (5) . Our high prevalence could be related to the existence in our center of the Safety Monitoring Adverse Effect Registry of Antipsychotics in Children and Adolescents (18). Parents with patients in need for treatment with antipsychotics may prefer to be followed in our outpatient unit as they perceive the benefit of a regular safety follow-up managed by clinical pharmacologists and psychiatrists.…”

Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives

“…NCT02007928 on www.clinicaltrials.gov); SENTIA: a systematic online monitoring registry for children and adolescents treated with antipsychotics, supported by the Spanish Ministry of Health and Social Politics (Palanca-Maresca et al, 2014);…”