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. 2014 Apr 14:3:187.
doi: 10.1186/2193-1801-3-187. eCollection 2014.

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

Inmaculada Palanca-Maresca  1 , Belén Ruiz-Antorán  2 , Gustavo Centeno-Soto  2 , Sara Jiménez-Fernandez  3 , Lourdes García-Murillo  4 , Ana Siles  5 , Sandra Villagrá  6 , Hilario Blasco-Fontecilla  7 , Luis Iruela-Cuadrado  8 , Enriqueta Roman-Riechman  9 , Cristina Avendaño-Solá  2 , Christoph U Correll  10
Affiliations

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

Inmaculada Palanca-Maresca et al. Springerplus. .

Abstract

Introduction: Despite 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.

Methods: We 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.

Results: Since 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.

Conclusions: Implementation of a systematic online pharmacovigilance system for antipsychotic adverse effects in youth is feasible and promises to generate important information.

Keywords: Adolescents; Adverse effects; Antipsychotics; Children; Pharmacovigilance; Registry.

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Figures

Figure 1
Figure 1
Overall appearance of online data recording ( https://SENTIA.es ).
See this image and copyright information in PMC

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