Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial.

ABSTRACT:

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 (G

SUBMITTER: Deb S 

PROVIDER: S-EPMC7485257 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature