Study protocol for SKIPMDD: subcutaneous ketamine infusion in palliative care patients with advanced life limiting illnesses for major depressive disorder (phase II pilot feasibility study).
clinical pharmacology
depression & mood disorders
palliative care
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
28 06 2021
28 06 2021
Historique:
entrez:
29
6
2021
pubmed:
30
6
2021
medline:
4
8
2021
Statut:
epublish
Résumé
Major depressive disorder (MDD) in people with advanced life-limiting illnesses can have significant impact on the quality-of-life of those affected. The management of MDD in the palliative care setting can be challenging as typical antidepressants may not work in time nor be tolerated due to coexisting organ dysfunctions, symptom burden and frailty. Parenteral ketamine was found to exhibit effective and rapid-onset antidepressant effect even against treatment-resistant depression in the psychiatric population. However, there is currently neither feasibility study nor available prospective study available to inform of the safety, tolerability and efficacy of such for MDD in the palliative setting. This is an open-labelled, single arm, phase II pilot feasibility study involving adult patients with advanced life-limiting illnesses and MDD across four palliative care services in Australia. It has an individual dose-titration design (0.1-0.4 mg/kg) with weekly treatments of subcutaneous ketamine infusion over 2 hours. The primary outcome is feasibility. The secondary outcomes are related to the safety, tolerability and antidepressant efficacy of ketamine, participants' satisfaction in relation to the trial process and the reasons for not completing the study at various stages. The feasibility data will be reported using descriptive statistics. Meanwhile, side effects, tolerability and efficacy data will be analysed using change of assessment scores from baseline. Ethics approval was acquired (South Western Sydney Local Health District: HREC/18/LPOOL/466). The results of this study will be submitted for publication in peer-reviewed journals and presented at relevant conferences. Australian New Zealand Clinical Trial Registry Number: ACTRN12618001586202; Pre-results.
Identifiants
pubmed: 34183351
pii: bmjopen-2021-052312
doi: 10.1136/bmjopen-2021-052312
pmc: PMC8240583
doi:
Substances chimiques
Ketamine
690G0D6V8H
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e052312Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: CL has served on an Advisory Board for Janssen-Cilag and as a consultant for Douglas Pharmaceuticals.
Références
Breast Cancer Res Treat. 2001 Nov;70(1):1-10
pubmed: 11766999
Psychosomatics. 1998 Jul-Aug;39(4):366-70
pubmed: 9691706
J Psychiatr Ment Health Nurs. 2011 Oct;18(8):744-50
pubmed: 21896118
JAMA. 2000 Dec 13;284(22):2907-11
pubmed: 11147988
Palliat Support Care. 2020 Feb;18(1):110-112
pubmed: 31397251
BMC Med Ethics. 2013 Dec 13;14:54
pubmed: 24330745
Am J Psychiatry. 1994 Apr;151(4):537-40
pubmed: 7511875
Neuropharmacology. 2012 Jan;62(1):63-77
pubmed: 21827775
J Palliat Med. 2005 Feb;8(1):49-57
pubmed: 15662173
CNS Neurosci Ther. 2013 Jun;19(6):370-80
pubmed: 23575437
J Trauma Stress. 1998 Jan;11(1):125-36
pubmed: 9479681
Am J Geriatr Psychiatry. 2017 Nov;25(11):1199-1209
pubmed: 28739263
J Pain Symptom Manage. 2021 Jan;61(1):143-166.e2
pubmed: 32688012
J Palliat Med. 2008 Nov;11(9):1268-71
pubmed: 19021495
World J Biol Psychiatry. 2014 Sep;15(7):579-84
pubmed: 24910102
Cancer. 1984 May 15;53(10 Suppl):2243-9
pubmed: 6704912
Psychosomatics. 1996 Jan-Feb;37(1):57-62
pubmed: 8600496
Psychooncology. 2017 Nov;26(11):1763-1769
pubmed: 27429350
J Palliat Care. 2010 Autumn;26(3):176-83
pubmed: 21047040
Biol Psychiatry. 2013 Aug 15;74(4):250-6
pubmed: 22840761
Arch Gen Psychiatry. 2006 Aug;63(8):856-64
pubmed: 16894061
Crit Rev Oncol Hematol. 2012 Jan;81(1):58-74
pubmed: 21429761
Palliat Med. 2011 Jan;25(1):36-51
pubmed: 20935027
J Palliat Med. 2008 Mar;11(2):158-63
pubmed: 18333728
CNS Neurosci Ther. 2013 Jun;19(6):428-36
pubmed: 23578128
Am J Psychiatry. 2006 Aug;163(8):1323-34
pubmed: 16877642
Psychol Med. 2015 Mar;45(4):693-704
pubmed: 25010396
Acta Psychiatr Scand. 2016 Jul;134(1):48-56
pubmed: 27028832
Gen Hosp Psychiatry. 2009 May-Jun;31(3):225-32
pubmed: 19410101
J Neuropsychiatry Clin Neurosci. 2015 Fall;27(4):362-4
pubmed: 25658683
BMJ Support Palliat Care. 2012 Dec;2(4):328-33
pubmed: 24654216
J Palliat Med. 2013 Aug;16(8):958-65
pubmed: 23805864
Aust Health Rev. 2014 Feb;38(1):44-50
pubmed: 24308902
J Palliat Med. 2019 Sep;22(9):1154-1161
pubmed: 31090477
Palliat Med. 2004 Apr;18(3):234-8
pubmed: 15198136
J Psychopharmacol. 2013 May;27(5):444-50
pubmed: 23428794
J Clin Psychopharmacol. 2006 Dec;26(6):653-6
pubmed: 17110825
J Clin Psychiatry. 2008 Jan;69(1):87-94
pubmed: 18312042
J Clin Oncol. 2002 Jan 1;20(1):335-9
pubmed: 11773187
Neuropsychiatr Dis Treat. 2016 Nov 03;12:2859-2867
pubmed: 27843321
Ann Intern Med. 2000 Feb 1;132(3):209-18
pubmed: 10651602
Support Care Cancer. 2020 Apr;28(4):1597-1606
pubmed: 31858251
Palliat Med. 1999 May;13(3):243-8
pubmed: 10474711
Support Care Cancer. 2012 Nov;20(11):2837-43
pubmed: 22361827
J Clin Oncol. 2012 Oct 10;30(29):3611-7
pubmed: 22965960
J Palliat Med. 2012 Apr;15(4):400-3
pubmed: 22468772
Br J Psychiatry. 1979 Apr;134:382-9
pubmed: 444788
Br J Cancer. 2008 Jun 17;98(12):1934-43
pubmed: 18506146
Am J Psychiatry. 2015 Oct;172(10):950-66
pubmed: 26423481
Cochrane Database Syst Rev. 2010 Mar 17;(3):CD007503
pubmed: 20238354
J Clin Oncol. 2011 Mar 20;29(9):1151-8
pubmed: 21300920
Psychosomatics. 1987 Sep;28(9):455-61
pubmed: 3432548
J Eval Clin Pract. 2004 May;10(2):307-12
pubmed: 15189396
Psychopharmacol Bull. 1993;29(2):321-6
pubmed: 8290681
J Clin Oncol. 2017 Nov 20;35(33):3753-3759
pubmed: 28968172
J Clin Psychiatry. 2015 Mar;76(3):247-52
pubmed: 25271445
Int Psychogeriatr. 2021 Feb;33(2):179-191
pubmed: 32600480
Gerontologist. 2008 Oct;48(5):593-602
pubmed: 18981276
Am J Psychiatry. 1999 Sep;156(9):1380-4
pubmed: 10484948
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
Pain. 1999 Aug;82(2):111-125
pubmed: 10467917
Palliat Med. 2013 Jun;27(6):486-98
pubmed: 22988044
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660
Psychopharmacology (Berl). 2014 Sep;231(18):3663-76
pubmed: 25038867
J Affect Disord. 2016 Dec;206:300-304
pubmed: 27656788
Ann Fam Med. 2010 Jul-Aug;8(4):348-53
pubmed: 20644190
Palliat Med. 2002 Mar;16(2):81-97
pubmed: 11969152
Biol Psychiatry. 2012 Jun 1;71(11):939-46
pubmed: 22297150
Psychosomatics. 2015 Jul-Aug;56(4):329-37
pubmed: 25616995
Am J Psychiatry. 2013 Oct;170(10):1134-42
pubmed: 23982301
Int J Neuropsychopharmacol. 2016 Apr 20;19(4):
pubmed: 26578082
Lancet Oncol. 2011 Feb;12(2):160-74
pubmed: 21251875
Aging Ment Health. 2016 Dec;20(12):1230-1242
pubmed: 26312455
J Am Geriatr Soc. 2007 Apr;55(4):596-602
pubmed: 17397440
Neuro Endocrinol Lett. 2013;34(4):287-93
pubmed: 23803871
Int J Environ Res Public Health. 2018 Aug 16;15(8):
pubmed: 30115817
Biol Psychiatry. 2014 Dec 15;76(12):970-6
pubmed: 24821196
Am J Hosp Palliat Care. 2013 Aug;30(5):450-4
pubmed: 22833552
Lancet Psychiatry. 2018 Jan;5(1):65-78
pubmed: 28757132