Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial
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Author(s)
Type
Journal Article
Abstract
Objectives: To conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).
Design: Multi-centre, 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 TBI patients over 18 months. Follow up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour (MOAS-primary outcome, IRQ) as well as global functioning (GOS-E, CGI) and quality of life (EQ-5D-5L, SF-12), mental health (HADS) and medication adverse effects (UKU).
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 study.
Trial registration number: ISRCTN30191436; 19th December 2016. EudraCT no. 2015-000641-23.
Design: Multi-centre, 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 TBI patients over 18 months. Follow up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour (MOAS-primary outcome, IRQ) as well as global functioning (GOS-E, CGI) and quality of life (EQ-5D-5L, SF-12), mental health (HADS) and medication adverse effects (UKU).
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 study.
Trial registration number: ISRCTN30191436; 19th December 2016. EudraCT no. 2015-000641-23.
Date Issued
2020-09-10
Date Acceptance
2020-06-17
Citation
BMJ Open, 2020, 10
ISSN
2044-6055
Publisher
BMJ Journals
Journal / Book Title
BMJ Open
Volume
10
Copyright Statement
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Sponsor
National Institute for Health Research
National Institute for Health Research
UK DRI Ltd
Grant Number
PG-PB-1013-32054
NIHR-RP-011-048
'CR & T IMP'
Subjects
adult psychiatry
impulse control disorders
psychiatry
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status
Published
Article Number
ARTN e036300
Date Publish Online
2020-09-10