Investigating the Effectiveness and Tolerability of Intranasal Esketamine Among Older Adults With Treatment-Resistant Depression (TRD): A Post-hoc Analysis from the REAL-ESK Study Group.


Journal

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry
ISSN: 1545-7214
Titre abrégé: Am J Geriatr Psychiatry
Pays: England
ID NLM: 9309609

Informations de publication

Date de publication:
12 2023
Historique:
received: 10 05 2023
revised: 27 06 2023
accepted: 30 06 2023
medline: 10 11 2023
pubmed: 22 7 2023
entrez: 21 7 2023
Statut: ppublish

Résumé

Treatment-resistant depression (TRD) is a serious and debilitating psychiatric disorder that frequently affects older patients. Esketamine nasal spray (ESK-NS) has recently been approved as a treatment for TRD, with multiple studies establishing its efficacy and tolerability. However, the real-world effectiveness, tolerability, and safety of this treatment in older adults is still unclear. To evaluate the efficacy and tolerability of ESK-NS in older subjects with TRD. This is a post-hoc analysis of the REAL-ESK study, a multicenter, retrospective, observational study. Participants here selected were 65 years or older at baseline. The Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) were used to assess depressive and anxiety symptoms, respectively. Data were collected at three-time points: baseline, 1 month after the start of treatment (T1), and 3 months after treatment (T2). The sample included older adults with TRD (n = 30). MADRS and HAM-A values decreased significantly at T1 (T0 versus T1: p Our findings provide preliminary evidence of ESK-NS effectiveness in older adults with TRD, a highly debilitating depressive presentation. Furthermore, we observe high levels of treatment-emergent adverse events, which, in the majority of instances, did not require treatment suspension.

Identifiants

pubmed: 37479669
pii: S1064-7481(23)00351-2
doi: 10.1016/j.jagp.2023.06.016
pii:
doi:

Substances chimiques

Antidepressive Agents 0
Esketamine 50LFG02TXD
Ketamine 690G0D6V8H

Types de publication

Observational Study Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1032-1041

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

DISCLOSURES Giovanni Martinotti has been a consultant and/or a speaker and/or has received research grants from Angelini, Doc Generici, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Servier, Neuraxpharm, Rovi, and Recordati. Giorgio Di Lorenzo has been a speaker and / or a consultant for Angelini, Janssen-Cilag, Livanova, Lundbeck, Neuraxpharm, Otsuka, and Recordati. Dr. Roger McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie, Atai Life Sciences. Dr. Roger McIntyre is the CEO of Braxia Scientific Corp. The remaining authors declare that the research was conducted without any commercial or financial relationship that could be construed as a potential conflict of interest.

Auteurs

Giacomo d'Andrea (G)

Department of Neurosciences, Imaging and Clinical Sciences (GDA, SC, GS, RCSLS, MP, GM), Università degli Studi G. D'Annunzio, Chieti, Italy.

Stefania Chiappini (S)

Department of Neurosciences, Imaging and Clinical Sciences (GDA, SC, GS, RCSLS, MP, GM), Università degli Studi G. D'Annunzio, Chieti, Italy. Electronic address: stefaniachiappini9@gmail.com.

Roger S McIntyre (RS)

Department of Pharmacology and Toxicology (RSM), University of Toronto, Toronto, ON, Canada; Mood Disorders Psychopharmacology Unit (RSM), University Health Network, Toronto, ON, Canada; Department of Psychiatry (RSM), University of Toronto, Toronto, ON Canada; Braxia Health, Canadian Centre for Rapid Treatment Excellence (CRTCE) (RSM), Mississauga, ON, Canada; Brain and Cognition Discovery Foundation (RSM), Toronto, ON, Canada.

Giulia Stefanelli (G)

Department of Neurosciences, Imaging and Clinical Sciences (GDA, SC, GS, RCSLS, MP, GM), Università degli Studi G. D'Annunzio, Chieti, Italy.

Rosalba Carullo (R)

Department of Neurosciences, Imaging and Clinical Sciences (GDA, SC, GS, RCSLS, MP, GM), Università degli Studi G. D'Annunzio, Chieti, Italy.

Ileana Andriola (I)

Università degli Studi di Bari Aldo Moro, (IA) Bari, Italy.

Raffaella Zanardi (R)

Department of Clinical Neurosciences, IRCCS San Raffaele Scientific Institute (RZ), Mood Disorder Unit, Milan, Italy; Department of Clinical Neurosciences (RZ), University Vita-Salute San Raffaele, Milan, Italy.

Vassilis Martiadis (V)

ASL Napoli 1 Centro, Department of Mental Health (VM), Napoli, Italy.

Stefano L Sensi (SL)

Department of Neurosciences, Imaging and Clinical Sciences (GDA, SC, GS, RCSLS, MP, GM), Università degli Studi G. D'Annunzio, Chieti, Italy.

Gabriele Sani (G)

Department of Neurosciences, Section of Psychiatry (GS), Università Cattolica del Sacro Cuore, Rome; Department of Psychiatry, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS (GS), Rome.

Massimo Clerici (M)

Department of Mental Health and Addiction (MC), Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy; School of Medicine and Surgery (MC), University of Milano-Bicocca, Monza, Italy.

Giorgio Di Lorenzo (G)

Chair of Psychiatry, Department of Systems Medicine (GDL), Tor Vergata University of Rome, Rome, Italy; IRCCS Fondazione Santa Lucia (GDL), Rome, Italy.

Antonio Vita (A)

Department of Clinical and Experimental Sciences (AV), University of Brescia, Brescia, Italy; Department of Mental Health and Addiction Services (AV), ASST Spedali Civili of Brescia, Brescia, Italy.

Mauro Pettorruso (M)

Department of Neurosciences, Imaging and Clinical Sciences (GDA, SC, GS, RCSLS, MP, GM), Università degli Studi G. D'Annunzio, Chieti, Italy.

Giovanni Martinotti (G)

Department of Neurosciences, Imaging and Clinical Sciences (GDA, SC, GS, RCSLS, MP, GM), Università degli Studi G. D'Annunzio, Chieti, Italy.

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