Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial
Objectives To conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).Design Multicentre, parallel design, placebo controlled (1:1 ratio) double-blind feasibility trial with an embedded process evaluation. No statis...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e036300.full |
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| author | Paul Bassett Tim Weaver Shoumitro Deb Mike Crawford David Sharp Lina Aimola Verity Leeson Mayur Bodani Lucia Li |
| author_facet | Paul Bassett Tim Weaver Shoumitro Deb Mike Crawford David Sharp Lina Aimola Verity Leeson Mayur Bodani Lucia Li |
| author_sort | Paul Bassett |
| collection | DOAJ |
| description | Objectives To conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).Design 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.Setting Four neuropsychiatric and neurology outpatient clinics in London and Kent, UK.Participants 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).Results 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.Conclusions 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.Trial registration number ISRCTN30191436 |
| format | Article |
| id | doaj-art-f450ad5cd11d4d26ba51aeb8e8f0e421 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f450ad5cd11d4d26ba51aeb8e8f0e4212025-01-08T16:40:11ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-036300Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trialPaul Bassett0Tim Weaver1Shoumitro Deb2Mike Crawford3David Sharp4Lina Aimola5Verity Leeson6Mayur Bodani7Lucia Li821 Medicine, Statsconsultancy, Amersham, UK3 Department of Mental Health & Social Work, Middlesex University, London, UKDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UKDepartment of Brain Sciences, Imperial College London Faculty of Medicine, London, UK1 Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College, London, United KingdomDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UKDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UKKent and Medway NHS and Social Care Partnership NHS Trust, Maidstone, UKDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UKObjectives To conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).Design 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.Setting Four neuropsychiatric and neurology outpatient clinics in London and Kent, UK.Participants 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).Results 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.Conclusions 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.Trial registration number ISRCTN30191436https://bmjopen.bmj.com/content/10/9/e036300.full |
| spellingShingle | Paul Bassett Tim Weaver Shoumitro Deb Mike Crawford David Sharp Lina Aimola Verity Leeson Mayur Bodani Lucia Li Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial BMJ Open |
| title | Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial |
| title_full | Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial |
| title_fullStr | Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial |
| title_full_unstemmed | Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial |
| title_short | Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial |
| title_sort | risperidone versus placebo for aggression following traumatic brain injury a feasibility randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/9/e036300.full |
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