The main objective of ETAPE study was to determine the incidence of adverse events (AEs) potentially related to antipsychotic (AP) during a 12-months observational study of naturalistic treatment. ETAPE is a naturalistic prospective multicenter study conducted between April 2013 and May 2016. 200 patients were included. The mean age was 12 ± 3 years, with 73.6% being males. Patients presented a significant clinical improvement over time. At baseline, 92% of patients received a second generation AP, 74% AP monotherapy and 79.5% off-label AP prescriptions. Clinical diagnoses were heterogeneous including psychosis, anxiety, mood and neurodevelopmental disorders. The overall AE incidence rate was 11.52 AEs per person-years. Among AEs potentially attributable to AP, 15.4% were neuromotor, 14.8% gastroenterological, 12.2% metabolic and 11.8% general symptoms. Weight and body mass index increased significantly. More than half of AE appeared during the first 3 months, but onset of AE was noted all over follow-up. The presence of AEs was stable over time. ETAPE study highlights a high incidence rate of AE in children treated with AP. A careful and continuous clinical and biological monitoring is required to adapt treatment decisions based on benefice-risk-analysis. Moreover, additional research is warranted, also in regard of high proportion of off-label prescriptions.

中文翻译：

---

接受抗精神病药物治疗的未使用抗精神病药物的儿童和青少年的不良事件发生率：多中心自然研究 (ETAPE) 的结果

ETAPE 研究的主要目的是在一项为期 12 个月的自然疗法观察性研究中确定可能与抗精神病药 (AP) 相关的不良事件 (AE) 的发生率。ETAPE 是一项自然主义前瞻性多中心研究，于 2013 年 4 月至 2016 年 5 月期间进行。包括 200 名患者。平均年龄为 12 ± 3 岁，其中 73.6% 为男性。随着时间的推移，患者表现出显着的临床改善。在基线时，92% 的患者接受了第二代 AP、74% 的 AP 单药治疗和 79.5% 的超说明书 AP 处方。临床诊断具有异质性，包括精神病、焦虑、情绪和神经发育障碍。总 AE 发生率为每人年 11.52 次 AE。在可能归因于 AP 的 AE 中，15.4% 为神经运动、14.8% 胃肠道、12.2% 代谢和 11。8% 一般症状。体重和体重指数显着增加。超过一半的 AE 出现在前 3 个月，但在整个随访期间都注意到 AE 的发生。随着时间的推移，AE 的存在是稳定的。ETAPE 研究强调了接受 AP 治疗的儿童的 AE 发生率很高。需要仔细和持续的临床和生物学监测，以适应基于受益风险分析的治疗决策。此外，还需要进行额外的研究，也涉及高比例的标签外处方。需要仔细和持续的临床和生物学监测，以适应基于受益风险分析的治疗决策。此外，还需要进行额外的研究，也涉及高比例的标签外处方。需要仔细和持续的临床和生物学监测，以适应基于受益风险分析的治疗决策。此外，还需要进行额外的研究，也涉及高比例的标签外处方。