Palanca-Maresca Inmaculada, Ruiz-Antorán Belén, Centeno-Soto Gustavo, Jiménez-Fernandez Sara, García-Murillo Lourdes, Siles Ana, Villagrá Sandra, Blasco-Fontecilla Hilario, Iruela-Cuadrado Luis, Roman-Riechman Enriqueta, Avendaño-Solá Cristina, Correll Christoph U
Department of Psychiatry, Puerta de Hierro University Hospital, Madrid, Spain ; Calle Manuel de Falla, 1, 28222 Majadahonda, Madrid, Spain.
Department of Clinical Pharmacology, Puerta de Hierro University Hospital, Madrid, Spain.
Springerplus. 2014 Apr 14;3:187. doi: 10.1186/2193-1801-3-187. eCollection 2014.
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.
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.
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.
Implementation of a systematic online pharmacovigilance system for antipsychotic adverse effects in youth is feasible and promises to generate important information.
尽管青少年抗精神病药物的处方量急剧增加，但关于其在这一脆弱人群中的安全性数据仍然有限，因此需要更多工具来收集长期的真实世界数据。
自2011年1月17日以来，一个初始中心纳入了85名青少年（年龄11.5±2.9（范围=4-17）岁，70.6%为男性）。平均随访17±11（范围=1-34）个月后，78.8%的患者仍在积极随访中。出于可行性考虑，取消了诊断访谈和详细的精神病理学量表。其余数据可在30分钟内录入。目前SENTIA正在增加几个其他中心。
为青少年抗精神病药物不良反应实施系统性在线药物警戒系统是可行的，有望产生重要信息。
