ECHO: Results from a Non-Interventional Cohort Study of Esketamine Nasal Spray in Treatment Resistant Depression
G. Rosso, E. Constant, S. De Filippis, Y. Godinov, L. Häggström, A. Ibañez, Y. Kambarov, E. Olivier, J. M. Olivares, C. Reif-Leonhard, B. Rive, I. Turkoz, C. von Holt, D. Zeeuws, S. KöhlerIntroduction
Esketamine nasal spray (ESK-NS) in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor is indicated for treatment of adults with treatment resistant depression (TRD) lacking response to ≥2 pharmacological treatments in the current moderate to severe depressive episode (Spravato SmPC; EMA). The ECHO study investigated ESK-NS efficacy and safety in real-world clinical settings.
Objectives
To present the first results of the ECHO study, which included patients (pts) with TRD initiating ESK-NS treatment in 7 participating countries.
Methods
ECHO was a prospective, international, non-interventional phase IV study. Eligible pts were adults diagnosed with TRD and prescribed ESK-NS independent of the study. The study comprised a screening/baseline period, an on-treatment period (variable duration) and a 6- month post-treatment follow-up ( Fig 1 ). Data were collected from routine clinical practice for clinical, social and economic outcomes, dosing, frequency and duration of treatment in clinical settings and pt outcomes. According to local regulations/clinical practice, pt-reported outcomes were also obtained.
Data collected at every visit included ESK-NS dosing/frequency, blood pressure before/after ESK-NS administration, concomitant medication/non-pharmacological treatments, time of and reasons for discontinuation (if applicable), and adverse events. At Weeks (Wks) 4, 8 and 12 (± 7 days), and then every 12 wks (± 15 days), data collection included various measures of depressive symptoms, clinical response, and pt-reported outcomes, including the Columbia Suicide Severity Rating Scale (C-SSRS). Montgomery-Åsberg Depression Rating Scale (MADRS) was assessed every 2 wks for 8 wks, then every 12 wks. Clinical management was reflective of local practice and at the sole discretion of the treating physician.
Statistical analyses will be descriptive (continuous variables) or summarised using frequencies and percentages (categorical variables).
Results
571 pts were enrolled in the ECHO study (Germany: 145; Italy: 124; Israel: 101; Belgium: 89; Spain: 59; Sweden: 42; Netherlands: 11). Baseline characteristics were representative of a broad pt population with TRD (Constant
et al
. ECNP 2025 [PS02-1216]). Analysis is ongoing; preliminary study results regarding effectiveness and safety of ESK-NS in a real-world setting will be reported in the poster, in addition to comorbidities and post- treatment follow-up outcomes.
Image 1: Long description.