Evidence map›Paper›PMID 32912978›Full record

Trial reportBMJ open2020

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

Shoumitro Deb, Lina Aimola, Verity Leeson, Mayur Bodani, Lucia Li, Tim Weaver, David Sharp, Paul Bassett, Mike Crawford

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Shoumitro DebDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK s.deb@imperial.ac.uk.ORCID 0000-0002-1300-8103
Lina AimolaDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.
Verity LeesonDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.
Mayur BodaniKent and Medway NHS and Social Care Partnership NHS Trust, Maidstone, UK.
Lucia LiDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.
Tim WeaverMiddlesex University, London, UK.
David SharpDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.
Paul BassettStatsconsultancy Ltd, London, UK.
Mike CrawfordDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.
Imperial College London · GBKent and Medway NHS and Social Care Partnership Trust · GBMiddlesex University · GB

Funding

Department of Health NIHR-RP-011-048Department of Health PB-PG-1013-32054
6 · The paper itself

Abstract

objectivesTo conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).

designMulticentre, 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 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).

resultsSix 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.

conclusionsIt 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.

Indexed as

Brain Injuries, TraumaticRisperidoneAdultAggressionDouble-Blind MethodFeasibility StudiesHumansLondonQuality of LifeRisperidoneadult psychiatryimpulse control disorderspsychiatry

Identifiers

PMID32912978
PMCPMC7485257
OpenAlexW3085854598

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.