title: SENTIA: a systematic online monitoring registry for children and adolescents treated with antipsychotics.
abstract: BACKGROUND
  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.
authors.affiliation: Department of Psychiatry, Puerta de Hierro University Hospital, Madrid, Spain ; Calle Manuel de Falla, 1, 28222 Majadahonda, Madrid, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Palanca-Maresca
authors.affiliation: Department of Clinical Pharmacology, Puerta de Hierro University Hospital, Madrid, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Ruiz-Antorán
authors.affiliation: Department of Clinical Pharmacology, Puerta de Hierro University Hospital, Madrid, Spain.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Centeno-Soto
authors.affiliation: Department of Psychiatry, Granada University, Granada, Spain.
authors.forename: Sara
authors.initials: S
authors.lastname: Jiménez-Fernandez
authors.affiliation: NYU Child Study Center, New York University, New York, USA.
authors.forename: Lourdes
authors.initials: L
authors.lastname: García-Murillo
authors.affiliation: Department of Cardiology, Puerta de Hierro University Hospital, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Siles
authors.affiliation: Department of Pediatric Cardiology, La Paz University Hospital, Madrid, Spain.
authors.forename: Sandra
authors.initials: S
authors.lastname: Villagrá
authors.affiliation: Department of Psychiatry, Puerta de Hierro University Hospital, CIBERSAM, Madrid, Spain.
authors.forename: Hilario
authors.initials: H
authors.lastname: Blasco-Fontecilla
authors.affiliation: Department of Psychiatry, Puerta de Hierro University Hospital, Madrid, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Iruela-Cuadrado
authors.affiliation: Department of Pediatrics, Puerta de Hierro University Hospital, Madrid, Spain.
authors.forename: Enriqueta
authors.initials: E
authors.lastname: Roman-Riechman
authors.affiliation: Department of Clinical Pharmacology, Puerta de Hierro University Hospital, Madrid, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Avendaño-Solá
authors.affiliation: The Zucker Hillside Hospital, Psychiatry Research, Glen Oaks, New York, USA.
authors.forename: Christoph U
authors.initials: CU
authors.lastname: Correll
keywords: Adolescents; Adverse effects; Antipsychotics; Children; Pharmacovigilance; Registry