Racemic Ketamine as an Alternative to Electroconvulsive Therapy for Unipolar Depression: A Randomized, Open-Label, Non-Inferiority Trial (KetECT).
Electroconvulsive therapy
ketamine infusion
major depressive disorder
psychotic depression
racemic ketamine
Journal
The international journal of neuropsychopharmacology
ISSN: 1469-5111
Titre abrégé: Int J Neuropsychopharmacol
Pays: England
ID NLM: 9815893
Informations de publication
Date de publication:
27 05 2022
27 05 2022
Historique:
received:
24
08
2021
revised:
19
11
2021
accepted:
03
12
2021
pubmed:
13
1
2022
medline:
3
6
2022
entrez:
12
1
2022
Statut:
ppublish
Résumé
Ketamine has emerged as a fast-acting and powerful antidepressant, but no head to head trial has been performed, Here, ketamine is compared with electroconvulsive therapy (ECT), the most effective therapy for depression. Hospitalized patients with unipolar depression were randomized (1:1) to thrice-weekly racemic ketamine (0.5 mg/kg) infusions or ECT in a parallel, open-label, non-inferiority study. The primary outcome was remission (Montgomery Åsberg Depression Rating Scale score ≤10). Secondary outcomes included adverse events (AEs), time to remission, and relapse. Treatment sessions (maximum of 12) were administered until remission or maximal effect was achieved. Remitters were followed for 12 months after the final treatment session. In total 186 inpatients were included and received treatment. Among patients receiving ECT, 63% remitted compared with 46% receiving ketamine infusions (P = .026; difference 95% CI 2%, 30%). Both ketamine and ECT required a median of 6 treatment sessions to induce remission. Distinct AEs were associated with each treatment. Serious and long-lasting AEs, including cases of persisting amnesia, were more common with ECT, while treatment-emergent AEs led to more dropouts in the ketamine group. Among remitters, 70% and 63%, with 57 and 61 median days in remission, relapsed within 12 months in the ketamine and ECT groups, respectively (P = .52). Remission and cumulative symptom reduction following multiple racemic ketamine infusions in severely ill patients (age 18-85 years) in an authentic clinical setting suggest that ketamine, despite being inferior to ECT, can be a safe and valuable tool in treating unipolar depression.
Sections du résumé
BACKGROUND
Ketamine has emerged as a fast-acting and powerful antidepressant, but no head to head trial has been performed, Here, ketamine is compared with electroconvulsive therapy (ECT), the most effective therapy for depression.
METHODS
Hospitalized patients with unipolar depression were randomized (1:1) to thrice-weekly racemic ketamine (0.5 mg/kg) infusions or ECT in a parallel, open-label, non-inferiority study. The primary outcome was remission (Montgomery Åsberg Depression Rating Scale score ≤10). Secondary outcomes included adverse events (AEs), time to remission, and relapse. Treatment sessions (maximum of 12) were administered until remission or maximal effect was achieved. Remitters were followed for 12 months after the final treatment session.
RESULTS
In total 186 inpatients were included and received treatment. Among patients receiving ECT, 63% remitted compared with 46% receiving ketamine infusions (P = .026; difference 95% CI 2%, 30%). Both ketamine and ECT required a median of 6 treatment sessions to induce remission. Distinct AEs were associated with each treatment. Serious and long-lasting AEs, including cases of persisting amnesia, were more common with ECT, while treatment-emergent AEs led to more dropouts in the ketamine group. Among remitters, 70% and 63%, with 57 and 61 median days in remission, relapsed within 12 months in the ketamine and ECT groups, respectively (P = .52).
CONCLUSION
Remission and cumulative symptom reduction following multiple racemic ketamine infusions in severely ill patients (age 18-85 years) in an authentic clinical setting suggest that ketamine, despite being inferior to ECT, can be a safe and valuable tool in treating unipolar depression.
Identifiants
pubmed: 35020871
pii: 6451171
doi: 10.1093/ijnp/pyab088
pmc: PMC9154276
doi:
Substances chimiques
Antidepressive Agents
0
Ketamine
690G0D6V8H
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
339-349Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of CINP.
Références
Aust N Z J Psychiatry. 2017 Jan;51(1):55-64
pubmed: 26893373
J Trauma Stress. 1998 Jan;11(1):125-36
pubmed: 9479681
Biol Psychiatry. 2013 Aug 15;74(4):250-6
pubmed: 22840761
Arch Gen Psychiatry. 2006 Aug;63(8):856-64
pubmed: 16894061
J Psychopharmacol. 2013 May;27(5):444-50
pubmed: 23428794
Depress Res Treat. 2011;2011:470985
pubmed: 22110913
Stat Med. 1998 Apr 30;17(8):873-90
pubmed: 9595617
Annu Rev Public Health. 2013;34:119-38
pubmed: 23514317
Psychiatry Clin Neurosci. 2018 Aug;72(8):623
pubmed: 29744959
J Affect Disord. 2016 Mar 15;193:203-7
pubmed: 26773921
Biol Psychiatry. 2000 Feb 15;47(4):351-4
pubmed: 10686270
J Affect Disord. 2016 Dec;206:300-304
pubmed: 27656788
J Clin Psychopharmacol. 2014 Apr;34(2):285-6
pubmed: 24525638
Lancet Psychiatry. 2018 Jan;5(1):65-78
pubmed: 28757132
Am J Psychiatry. 2016 Aug 1;173(8):816-26
pubmed: 27056608
Mol Psychiatry. 2020 Jul;25(7):1592-1603
pubmed: 30283029
Acta Psychiatr Scand. 2016 Jul;134(1):48-56
pubmed: 27028832
Ann Clin Psychiatry. 2007 Jan-Mar;19(1):1-4
pubmed: 17453654
Int J Neuropsychopharmacol. 2014 Nov;17(11):1805-13
pubmed: 24963561
Br J Psychiatry. 1979 Apr;134:382-9
pubmed: 444788
J Clin Psychiatry. 2004 Apr;65(4):485-91
pubmed: 15119910
Biol Psychiatry. 2010 Jan 15;67(2):139-45
pubmed: 19897179
Psychiatry Res. 2014 Feb 28;215(2):355-61
pubmed: 24374115
J Affect Disord. 2017 Oct 15;221:283-288
pubmed: 28666206
Psychother Psychosom. 2017;86(3):162-167
pubmed: 28490030
Biol Psychiatry. 2010 Sep 15;68(6):568-77
pubmed: 20673880
J Clin Psychopharmacol. 2018 Dec;38(6):590-597
pubmed: 30346333
Curr Psychiatry Rep. 2016 Apr;18(4):40
pubmed: 26909702
Am J Psychiatry. 2006 Nov;163(11):1905-17
pubmed: 17074942
Cochrane Database Syst Rev. 2015 Sep 23;(9):CD011612
pubmed: 26395901
Lancet. 2015 Nov 28;386(10009):2145-91
pubmed: 26321261
Neuro Endocrinol Lett. 2013;34(4):287-93
pubmed: 23803871
Br J Psychiatry. 2010 Mar;196(3):226-34
pubmed: 20194546