Aggression Following TBI: Effectiveness of Risperidone

Central and North West London NHS Foundation Trust0 个研究点目标入组 14 人开始时间: 2016年12月19日最近更新: 2020年9月28日

适应症

试验速览

•1. Aged between 18 and 65 years
•2. A confirmed clinical diagnosis of TBI which occurred at least six months prior to recruitment, evidenced as a rating of moderate/severe or mild (probable) based on Mayo Clinic criteria
•3. 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
•4. Competent and willing to provide written, informed consent
•5. The patient or their carer is able to understand how to manage prescribed medication

•1. Suffering from Post-Traumatic Amnesia (PTA), which constitutes a sub-acute confusional state
•2. Co-morbid severe mental illness such as schizophrenia and other psychoses, bipolar disorder, major depressive disorder, personality disorder, and dementia, and where the clinicians are treating primarily a psychiatric disorder rather than aggressive behaviour
•3. Already prescribed an antipsychotic drug or any other drug that may interact with risperidone at the time of randomisation. A wash-out period of at least two weeks is required prior to randomisation.
•4. Any other contraindication for using risperidone including a previous history of severe adverse events
•5. Has no fixed abode or any other reason for which compliance with trial medication and monitoring could pose a major problem
•6. Is pregnant or trying to conceive, breastfeeding, or a woman of childbearing potential not using a highly effective birth control
•7. Lactose intolerance
•8. Known cardiovascular disease (e.g., heart failure, myocardial infarction, conduction abnormalities including family history of QT prolongation, dehydration, hypovolaemia, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), or cerebrovascular disease
•9. A clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia
•10. A history of seizures

发起方