临床试验/NCT06518330

NCT06518330已完成不适用

Psychosis and Hallucinations in Methylphenidate-Treated Children: A Pharmacovigilance Study Using Vigibase

University Hospital, Caen1 个研究点分布在 1 个国家目标入组 46,233 人开始时间: 2024年7月24日最近更新: 2024年7月24日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University Hospital, Caen
入组人数: 46,233
试验地点: 1
主要终点: Correlation between methylphenidate and psychosis in children and adolescents using a disproportionality analysis in Individual Case Reports involving at least one liable drug with an indication in ADHD.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

perform a study in VigiBase® to assess if methylphenidate was associated with an over-reporting of psychosis including hallucinations in children and adolescents and to characterize those psychosis.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Retrospective

入排标准

年龄范围: 5 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Case reported in the World Health Organization (WHO) database of individual safety case reports until 16/02/2024 in children and adolescents treated with drugs with an indication in ADHD.
•Adverse events reported were including a list of MedDRA Preferred Terms related to psychosis

排除标准

•Chronology not compatible between the drug and the toxicity

研究组 & 干预措施

Patients presenting a possible drug-induced adverse effects

Drug: search for methylphenidate intake

干预措施: Intake of Methylphenidate (Drug)

结局指标

主要结局

Correlation between methylphenidate and psychosis in children and adolescents using a disproportionality analysis in Individual Case Reports involving at least one liable drug with an indication in ADHD.

时间窗: from the 01/01/1967 to the 16/02/2024

次要结局

未报告次要终点

研究者

发起方

University Hospital, Caen

申办方类型

Other

责任方

Sponsor

研究点 (1)

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