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

Antipsychotic Agents / therapeutic use Brain Injuries, Traumatic / complications Humans Olanzapine / therapeutic use Patient Discharge Psychomotor Agitation / drug therapy Randomized Controlled Trials as Topic Reproducibility of Results
Agitation Antipsychotic Olanzapine Pharmacological intervention Post-traumatic amnesia Randomised controlled trial Traumatic brain injury

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
20 Jul 2020
Historique:
received: 03 05 2020
accepted: 23 06 2020
entrez: 22 7 2020
pubmed: 22 7 2020
medline: 14 5 2021
Statut: epublish

Résumé

Agitation 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. Fifty-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. 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. ANZCTR ACTRN12619000284167 . Registered on 25 February 2019.

Sections du résumé

BACKGROUND BACKGROUND
Agitation 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.
METHODS METHODS
Fifty-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 CONCLUSIONS
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 REGISTRATION BACKGROUND
ANZCTR ACTRN12619000284167 . Registered on 25 February 2019.

Identifiants

DOI: 10.1186/s13063-020-04553-2 PMID: 32690072 PMC: PMC7370410
pubmed: 32690072
doi: 10.1186/s13063-020-04553-2
pii: 10.1186/s13063-020-04553-2
pmc: PMC7370410
doi:

Substances chimiques

Antipsychotic Agents 0
Olanzapine N7U69T4SZR

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

662

Subventions

Organisme : National Health and Medical Research Council
ID : APP1174473
Organisme : Epworth Healthcare
ID : Not Applicable
Organisme : Monash University
ID : Not Applicable

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Auteurs

Ruby K Phyland (RK)

Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia. ruby.phyland@monash.edu.
School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Clayton, Victoria, 3800, Australia. ruby.phyland@monash.edu.
Turner Institute for Brain and Mental Health, Monash University, Level 5, 18 Innovation Walk, Clayton Campus, Clayton, Victoria, 3800, Australia. ruby.phyland@monash.edu.
ORCID: 0000-0001-5465-3451

Adam McKay (A)

Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia.
School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Clayton, Victoria, 3800, Australia.
Turner Institute for Brain and Mental Health, Monash University, Level 5, 18 Innovation Walk, Clayton Campus, Clayton, Victoria, 3800, Australia.
Department of Psychology, Epworth HealthCare, 29 Erin Street, Richmond, Victoria, 3121, Australia.

John Olver (J)

Rehabilitation Medicine, Epworth HealthCare, 89 Bridge Rd, Richmond, Victoria, 3121, Australia.

Mark Walterfang (M)

Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North Block, Grattan Street, Parkville, Victoria, 3052, Australia.
Royal Melbourne Hospital, 300 Grattan St, Parkville, Victoria, 3050, Australia.
Florey Institute of Neuroscience and Mental Health, University of Melbourne, 30 Royal Parade, Parkville, Victoria, 3052, Australia.

Malcolm Hopwood (M)

Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North Block, Grattan Street, Parkville, Victoria, 3052, Australia.
Albert Road Clinic Professorial Psychiatry Unit, University of Melbourne, 31 Albert Rd, Melbourne, Victoria, 3004, Australia.

Amelia J Hicks (AJ)

Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia.
School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Clayton, Victoria, 3800, Australia.
Turner Institute for Brain and Mental Health, Monash University, Level 5, 18 Innovation Walk, Clayton Campus, Clayton, Victoria, 3800, Australia.

Duncan Mortimer (D)

Centre for Health Economics, Monash Business School, Monash University, Building H, Level 5, Caulfield Campus, Clayton, Victoria, 3145, Australia.

Jennie L Ponsford (JL)

Monash Epworth Rehabilitation Research Centre, 185-187 Hoddle Street, Richmond, Victoria, 3121, Australia.
School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton Campus, Wellington Road, Clayton, Victoria, 3800, Australia.
Turner Institute for Brain and Mental Health, Monash University, Level 5, 18 Innovation Walk, Clayton Campus, Clayton, Victoria, 3800, Australia.

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents du système nerveux central › Psychoanaleptiques › Tranquillisants › Neuroleptiques › Use of olanzapine to treat agitation in...
questionsmedicales.fr › Plaies et blessures › Traumatismes du système nerveux › Traumatismes cranioencéphaliques › Lésions encéphaliques › Lésions traumatiques de l'encéphale › Use of olanzapine to treat agitation in...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Use of olanzapine to treat agitation in...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Benzazépines › Benzodiazépines › Olanzapine › Use of olanzapine to treat agitation in...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Services de santé polyvalents › Soins de santé primaires › Continuité des soins › Sortie du patient › Use of olanzapine to treat agitation in...
questionsmedicales.fr › Comportement et mécanismes comportementaux › Manifestations neurocomportementales › Troubles psychomoteurs › Agitation psychomotrice › Use of olanzapine to treat agitation in...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Use of olanzapine to treat agitation in...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Reproductibilité des résultats › Use of olanzapine to treat agitation in...