Evidence map›Paper›PMID 32690072›Full record

ArticleTrials2020

Use of olanzapine to treat agitation in traumatic brain injury: study protocol for a randomised controlled trial.

Ruby K Phyland, Adam McKay, John Olver, Mark Walterfang, Malcolm Hopwood, Amelia J Hicks, Duncan Mortimer, Jennie L Ponsford

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 27% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. 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

8 authors at 4 institutions in 2 countries.

Ruby K PhylandMonash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia. ruby.phyland@monash.edu.ORCID http://orcid.org/0000-0001-5465-3451
Adam McKayMonash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia.
John OlverRehabilitation Medicine, Epworth HealthCare, 89 Bridge Rd, Richmond, Victoria, 3121, Australia.
Mark WalterfangDepartment of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North Block, Grattan Street, Parkville, Victoria, 3052, Australia.
Malcolm HopwoodDepartment of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North Block, Grattan Street, Parkville, Victoria, 3052, Australia.
Amelia J HicksMonash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia.
Duncan MortimerCentre for Health Economics, Monash Business School, Monash University, Building H, Level 5, Caulfield Campus, Clayton, Victoria, 3145, Australia.
Jennie L PonsfordMonash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia.
Epworth Hospital · AUMonash University · AUThe Royal Melbourne Hospital · AUVictoria and Albert Museum · GB

Funding

Epworth Healthcare Not ApplicableMonash University Not ApplicableNational Health and Medical Research Council APP1174473
6 · The paper itself

Abstract

backgroundAgitation is common in the early stages of recovery from traumatic brain injury (TBI), when patients are in post-traumatic amnesia (PTA). Agitation is associated with risk of harm to patients and caregivers. Recent guidelines recommend that agitation during PTA is managed using environmental modifications. Agitation is also frequently treated pharmacologically, with the use of atypical antipsychotics such as olanzapine among the most common. This is despite a lack of well-designed studies to support the use of antipsychotics within this context. This study will be a double-blind, placebo-controlled randomised controlled trial. We will examine the efficacy, safety, cost-effectiveness and outcomes associated with the use of olanzapine for reducing agitation in patients in PTA following TBI over and above recommended environmental management.

methodsFifty-eight TBI rehabilitation inpatients who are in PTA and are agitated will receive olanzapine or placebo for the duration of PTA. All participants will additionally receive optimal environmental management for agitation. Measures of agitation, PTA and health will be undertaken at baseline. Treatment administration will begin at a dose of 5 mg daily and may be escalated to a maximum dose of 20 mg per day. Throughout the treatment period, agitation and PTA will be measured daily, and adverse events monitored weekly. Efficacy will be assessed by treatment group comparison of average Agitated Behaviour Scale scores during PTA. Participants will cease treatment upon emergence from PTA. Agitation levels will continue to be monitored for a further 2 weeks, post-treatment measures of health will be undertaken and cognitive and functional status will be assessed. Level of agitation and functional health will be assessed at hospital discharge. At 3 months post-discharge, functional outcomes and health service utilisation will be measured. DISCUSSION: This trial will provide crucial evidence to inform the management of agitation in patients in PTA following TBI. It will provide guidance as to whether olanzapine reduces agitation over and above recommended environmental management or conversely whether it increases or prolongs agitation and PTA, increases length of inpatient hospitalisation and impacts longer term cognitive and functional outcomes. It will also speak to the safety and cost-effectiveness of olanzapine use in this population.

trial registrationANZCTR ACTRN12619000284167 . Registered on 25 February 2019.

Indexed as

Brain Injuries, TraumaticAntipsychotic AgentsHumansOlanzapinePatient DischargePsychomotor AgitationRandomized Controlled Trials as TopicReproducibility of ResultsAntipsychotic AgentsOlanzapineAgitationAntipsychoticOlanzapinePharmacological interventionPost-traumatic amnesiaRandomised controlled trialTraumatic brain injury

Identifiers

PMID32690072
PMCPMC7370410
OpenAlexW3042888141

What OpenQuestion 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 OpenQuestion graph.