Imperial College London
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ProfessorMikeCrawford

Faculty of Medicine, Department of Brain Sciences

Professor of Mental Health Research
 
 
 
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Contact

 

+44 (0)20 3313 4161m.crawford

 
 
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Assistant

 

Ms Nicole Hickey +44 (0)20 3313 4161

 
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Location

 

Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Deb:2020:10.1136/bmjopen-2019-036300,
author = {Deb, S and Crawford, M and Sharp, D and Leeson, V and Aimola, L and Li, L and Weaver, T and Bodani, M and Bassett, P},
doi = {10.1136/bmjopen-2019-036300},
journal = {BMJ Open},
title = {Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial},
url = {http://dx.doi.org/10.1136/bmjopen-2019-036300},
volume = {10},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - 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.SettingFour neuropsychiatric and neurology outpatient clinics in London and Kent, UK. ParticipantsOur 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 s
AU  - Deb,S
AU  - Crawford,M
AU  - Sharp,D
AU  - Leeson,V
AU  - Aimola,L
AU  - Li,L
AU  - Weaver,T
AU  - Bodani,M
AU  - Bassett,P
DO  - 10.1136/bmjopen-2019-036300
PY  - 2020///
SN  - 2044-6055
TI  - Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial
T2  - BMJ Open
UR  - http://dx.doi.org/10.1136/bmjopen-2019-036300
UR  - http://hdl.handle.net/10044/1/81049
VL  - 10
ER  -
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