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

Giacomo d’Andre, Roger S. McIntyre, Stefania Chiappini, Giulia Stefanelli, Rosalba Carullo, Ileana Andriola, Raffaella Zanardi, Vassillis Martiadis, Stefano L. Sensi, Gabriele Sani, Massimo Clerici, Giorgio Di Lorenzo, Antonio Vita, Mauro Pettorruso, Giovanni Martinotti

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: 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.
Objectives: To evaluate the efficacy and tolerability of ESK-NS in older subjects with TRD.
Methods: 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, one month after the start of treatment (T1), and three months after treatment (T2).
Results: The sample included older adults with TRD (n=30). MADRS and HAM-A values decreased significantly at T1 (T0vsT1: pholm<0.001, Cohen's d=0.840) and T2 follow-ups (T0vsT2: pholm<0.001, Cohen's d=1.419). At T2, 53.3% of subjects were responders (MADRS score reduced ≥ 50%), while 33.33% were in remission (MADRS<10). ESK-NS-related adverse effects were in order of frequency dizziness (50%), followed by dissociation (33.3%), sedation (30%), and hypertension (13.33%). Six out of 30 participants (20%) discontinued treatment.
Conclusions: 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.

Original languageEnglish
JournalAmerican Journal of Geriatric Psychiatry
Publication statusAccepted/In press - 5 Jul 2023

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