Aggression Following TBI: Effectiveness of Risperidone (AFTER)-a feasibility RCT. - AFTER

Central and North West London NHS Foundation Trust0 个研究点目标入组 14 人开始时间: 2019年2月6日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- Age 18 to 65 years.
•- A confirmed clinical diagnosis of TBI which happened at least six months prior to recruitment.
•- Referred to the clinician for the management of aggression and for whom the clinician is considering a pharmacological intervention for this problem after investigating and addressing physical, psychological and social triggers.
•- Is able to give written, informed consent, as judged by a medically qualified doctor.
•- The patient or their carer is able to understand how to manage prescribed medication, as determined by discussion at the screening assessment.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Suffering from Post-Traumatic Amnesia (PTA), which constitutes a sub-acute confusional state.
•- Co-morbid serious mental illness such as schizophrenia and other psychoses, bipolar disorder, major depressive disorder, personality disorder, and dementia.
•- Already prescribed an antipsychotic drug or any other drug that may interact with risperidone at the time of randomisation.
•- Any other contraindication for using risperidone including a previous history of severe adverse events.
•- Has no fixed abode or any other reason for which compliance with trial medication and monitoring could pose a major problem.
•-Is pregnant or trying to conceive, as determined by self-report.
•-Lactose intolerance

发起方