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.
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 language | English |
|---|---|
| Journal | American Journal of Geriatric Psychiatry |
| Publication status | Accepted/In press - 5 Jul 2023 |