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’andrea, Stefania Chiappini, Roger S. McIntyre, Giulia Stefanelli, Rosalba Carullo, Ileana Andriola, Raffaella Zanardi, Vassilis Martiadis, Stefano L. Sensi, Gabriele Sani, Massimo Clerici, Giorgio Di Lorenzo, Antonio Vita, Mauro Pettorruso, Giovanni Martinotti
American Journal of Geriatric Psychiatry July 8, 2023 DOI: 10.1016/j.jagp.2023.06.016 via OpenAlex
Summary
Esketamine nasal spray (ESK-NS) shows preliminary effectiveness for treatment-resistant depression in adults aged 65 and older, with 53.3% of participants responding (MADRS score reduced by at least 50%) and 33.33% achieving remission (MADRS below 10) after three months. Common adverse effects included dizziness (50%), dissociation (33.3%), sedation (30%), and hypertension (13.33%). Twenty percent of participants discontinued treatment. These findings, from a post-hoc analysis of 30 older adults, suggest ESK-NS can be effective but is associated with high rates of treatment-emergent adverse events, most of which did not require stopping treatment.
Study at a glance
| Characteristics | Post-hoc analysis of a multicenter, retrospective, observational study Peer reviewed |
|---|---|
| Sample size | 30 |
| Population | Adults aged 65 years or older with treatment-resistant depression |
| Intervention | Esketamine nasal spray |
| Duration | 3 months |
| Topics | Anxiety Depression |
| Keywords | Tolerability Post-hoc analysis Internal medicine Depression economics |
| Citations | 36 |
| Key finding | Esketamine nasal spray was associated with a 53.3% response rate and 33.33% remission rate at 3 months in older adults with treatment-resistant depression, with common adverse effects including dizziness, dissociation, and sedation. |
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, 1 month after the start of treatment (T1), and 3 months after treatment (T2). RESULTS: <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.