AFTER
Research type
Research Study
Full title
Aggression Following TBI: Effectiveness of Risperidone (AFTER)-a feasibility RCT.
IRAS ID
163309
Contact name
Mike Crawford
Contact email
Sponsor organisation
Central and North West London NHS Foundation Trust
Eudract number
2015-000641-23
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
A multi-centre, parallel design, randomised, placebo controlled (1:1 ratio) double-blind feasibility trial in order to assess feasibility for a substantive full scale definitive RCT of risperidone versus placebo to treat aggression in adults with Traumatic Brain Injury (TBI). The trial will be conducted in secondary care mental health services, at four UK centres across London and in Kent. All those taking part in the study will continue to receive treatment as usual from primary and secondary care services. In addition, those randomised to active treatment will be prescribed up to 4mg of generic risperidone. Those randomised to the control treatment will receive treatment as usual plus an inert placebo. 50 patients will be recruited over a 18 month period, and each participant shall be assessed at baseline and thereafter on a weekly basis for 12 weeks. The primary outcome of the trial is aggression, which will be measured using the Modified Overt Aggression Scale (MOAS) to assess improvement. The MOAS is a simple but widely used 4-item scale that measures verbal aggression along with physical aggression towards other people, property and self. The MOAS is a valid and reliable instrument which has been used in many pharmacological intervention studies of aggression in different neuropsychiatric patient groups including TBI. In addition there will be a number of secondary outcome measures and a process evaluation.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1181
Date of REC Opinion
21 Sep 2015
REC opinion
Further Information Favourable Opinion