Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK
Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.
BMJ Open. 2020 Sep 10;10(9):e036300. doi: 10.1136/bmjopen-2019-036300.
To conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).
Multicentre, parallel design, placebo controlled (1:1 ratio) double-blind feasibility trial with an embedded process evaluation. No statistical comparison was performed between the two study groups.
Four neuropsychiatric and neurology outpatient clinics in London and Kent, UK.
Our aim was to recruit 50 patients with TBI over 18 months. Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).
Six participants were randomised to the active arm of the trial and eight to the placebo arm over a 10-month period (28% of our target). Two participants withdrew because of adverse events. Twelve out of 14 (85.7%) patients completed a follow-up assessment at 12 weeks. At follow-up, the scores of all outcome measures improved in both groups. Placebo group showed numerically better score change according to the primary outcome MOAS. No severe adverse events were reported. The overall rate of adverse events remained low. Data from the process evaluation suggest that existence of specialised TBI follow-up clinics, availability of a dedicated database of TBI patients' clinical details, simple study procedures and regular support to participants would enhance recruitment and retention in the trial. Feedback from participants showed that once in the study, they did not find the trial procedure onerous.
It was not feasible to conduct a successful randomised trial of risperidone versus placebo for post-TBI aggression using the methods we deployed in this study. It is not possible to draw any definitive conclusion about risperidone's efficacy from such a small trial.
ISRCTN30191436.
开展利培酮治疗创伤性脑损伤（TBI）成人攻击行为的可行性随机对照试验。
多中心、平行设计、安慰剂对照（1:1 比例）双盲可行性试验，嵌入过程评估。两个研究组之间未进行统计学比较。
英国伦敦和肯特的四个神经精神病学和神经病学门诊。
我们的目标是在 18 个月内招募 50 名 TBI 患者。使用一系列评估量表对 12 周时的随访参与者进行随访，以测量攻击行为和烦躁（改良外显攻击量表（MOAS）-主要结局、烦躁问卷）以及整体功能（格拉斯哥结局量表-扩展版，临床总体印象）和生活质量（EQ-5D-5L，SF-12）、心理健康（医院焦虑和抑郁量表）和药物不良反应（Udvalg for Kliniske Undersøgelser）的变化。
在 10 个月的时间里，有 6 名参与者被随机分配到试验的活性臂，8 名参与者被随机分配到安慰剂臂（占我们目标的 28%）。由于不良事件，有 2 名参与者退出。14 名患者中有 12 名（85.7%）在 12 周时完成了随访评估。随访时，两组所有结局指标的评分均有所改善。安慰剂组根据主要结局 MOAS 显示出数值上更好的评分变化。未报告严重不良事件。总的不良事件发生率仍然较低。过程评估中的数据表明，存在专门的 TBI 随访诊所、可用的 TBI 患者临床详细信息专用数据库、简单的研究程序和定期为参与者提供支持，将有助于招募和保留试验。参与者的反馈表明，一旦进入研究，他们不会觉得试验程序繁琐。
使用我们在这项研究中部署的方法，无法对利培酮与安慰剂治疗 TBI 后攻击行为进行成功的随机试验。从小规模试验中不可能得出关于利培酮疗效的任何明确结论。
ISRCTN30191436。
