PURPOSE: This study aimed to describe the prevalence of corrected QT (QTc) interval disorders and the possible predisposing factors in children and adolescents treated with antipsychotic (AP) medications in a real-world population with a long-term follow-up. METHODS: Data were obtained from the SafEty of NeurolepTics in Infancy and Adolescence (SENTIA) registry (https://sentia.es). The SENTIA includes patients younger than 18 years who are currently taking or initiating treatment with AP medications and have agreed to participate in the registry. The SENTIA's follow-up includes an electrocardiogram (ECG) assessment before starting treatment and at 1, 3, and 6 months after treatment initiation or after any changes in the patient's AP medication treatment. Thereafter, all participants undergo an ECG every 6 months. A QTc interval more than 450 milliseconds, increases in QTc interval of 60 milliseconds or more, or QTc dispersion more than 100 milliseconds were considered abnormal. RESULTS: Since January 1, 2011, 101 patients have been enrolled in SENTIA and have had at least 1 ECG assessment. The mean age at inclusion was 11.5 years; 75% of the patients were men. The mean follow-up time was 20.0 ± 15.1 months. The most frequently prescribed AP medications were risperidone (52.2%) and aripiprazole (45.5%). Seven patients (6.9%) had abnormal changes in QTc. No patient had a QTc interval more than 500 milliseconds. All patients were asymptomatic. The QTc changes were observed at different times of exposure, with a range of 1 to 39 months after beginning AP treatment. Concomitant use of attention deficit and hyperactivity disorder drugs seemed a possible factor associated with QTc disorders. CONCLUSIONS: Patients should undergo a baseline ECG assessment before starting AP medication treatment, particularly patients with concomitant use of attention deficit and hyperactivity disorder drugs or a family/personal history of heart disease.
PURPOSE: This study aimed to describe the prevalence of corrected QT (QTc) interval disorders and the possible predisposing factors in children and adolescents treated with antipsychotic (AP) medications in a real-world population with a long-term follow-up. METHODS: Data were obtained from the SafEty of NeurolepTics in Infancy and Adolescence (SENTIA) registry (https://sentia.es). The SENTIA includes patients younger than 18 years who are currently taking or initiating treatment with AP medications and have agreed to participate in the registry. The SENTIA's follow-up includes an electrocardiogram (ECG) assessment before starting treatment and at 1, 3, and 6 months after treatment initiation or after any changes in the patient's AP medication treatment. Thereafter, all participants undergo an ECG every 6 months. A QTc interval more than 450 milliseconds, increases in QTc interval of 60 milliseconds or more, or QTc dispersion more than 100 milliseconds were considered abnormal. RESULTS: Since January 1, 2011, 101 patients have been enrolled in SENTIA and have had at least 1 ECG assessment. The mean age at inclusion was 11.5 years; 75% of the patients were men. The mean follow-up time was 20.0 ± 15.1 months. The most frequently prescribed AP medications were risperidone (52.2%) and aripiprazole (45.5%). Seven patients (6.9%) had abnormal changes in QTc. No patient had a QTc interval more than 500 milliseconds. All patients were asymptomatic. The QTc changes were observed at different times of exposure, with a range of 1 to 39 months after beginning AP treatment. Concomitant use of attention deficit and hyperactivity disorder drugs seemed a possible factor associated with QTc disorders. CONCLUSIONS:Patients should undergo a baseline ECG assessment before starting AP medication treatment, particularly patients with concomitant use of attention deficit and hyperactivity disorder drugs or a family/personal history of heart disease.