Specialty: Mental Health, Primary sub-specialty: Physical Injury, Occupational Diseases, Poisoning Traumatic Brain Injury (TBI)
Conditions
Interventions
Eligible participants will be randomised to receive either risperidone or placebo at a ratio of 1:1, stratified by site. A flexible dosing regimen of risperdone will be used. Dosing will start with 1
Sponsors
Central and North West London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported aggression is measured using the Modified Overt Aggression Scale (MOAS) at baseline and weekly for 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Irritability is assessed using the Irritability Questionnaire (IRQ) at baseline and 12 weeks 2. Social functioning is measured using the Extended Glasgow Outcome Scale (GOS-E) at baseline and 12 weeks 3. Health-related Quality of life (QoL) is measured using the EQ-5D-5L and SF-12 questionnaires at baseline and 12 weeks 4. Adverse events profile is assessed using the UKU scale at baseline and 12 weeks 5. Carer Wellbeing is assessed using the wellbeing section of the 'carer wellbeing and support questionnaire (CWS) at baseline and 12 weeks 6. Health economics are assessed using the Client Service Receipt Inventory (CSRI) at baseline and 12 weeks | — |
Countries
United Kingdom
Outcome results
None listed