Efficacy of esketamine nasal spray over quetiapine extended release over the short and long term : Sensitivity analyses of ESCAPE-TRD, a randomised phase IIIb clinical trial
Young, Allan (Bethlem Royal Hospital)
Fagiolini, Andrea (University of Siena School of Medicine)
Falkai, Peter (Ludwig-Maximilians-University Munich)
Cardoner, Narcís (Institut de Recerca Sant Pau)
Nielsen, René E. (Aalborg Universitet)
Rive, Benoît (Janssen EMEA)
Diels, Joris (Janssen Pharmaceutica NV)
Reif, Andreas (Fraunhofer Institute for Translational Medicine and Pharmacology ITMP)
Llorca, Pierre-Michel (CHU Clermont-Ferrand)
Blomqvist, Ola (Capio Lundby Hospital)
Godinov, Yordan (Janssen EMEA)
Mulhern-Haughey, Siobhán (Janssen EMEA)
Universitat Autònoma de Barcelona. Departament de Medicina

Fecha:	2025
Resumen:	Background In patients with treatment resistant depression (TRD), the ESCAPE-TRD study showed esketamine nasal spray was superior to quetiapine extended release. Aims To determine the robustness of the ESCAPE-TRD results and confirm the superiority of esketamine nasal spray over quetiapine extended release. Method ESCAPE-TRD was a randomised, open-label, rater-blinded, active-controlled phase IIIb trial. Patients had TRD (i. e. non-response to two or more antidepressive treatments within a major depressive episode). Patients were randomised 1:1 to flexibly dosed esketamine nasal spray or quetiapine extended release, while continuing an ongoing selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor. The primary end-point was achieving a Montgomery-Åsberg Depression Rating Scale score of ≤10 at Week 8, while the key secondary end-point was remaining relapse free through Week 32 after achieving remission at Week 8. Sensitivity analyses were performed on these end-points by varying the definition of remission based on timepoint, threshold and scale. Results Of 676 patients, 336 were randomised to esketamine nasal spray and 340 to quetiapine extended release. All sensitivity analyses on the primary and key secondary end-point favoured esketamine nasal spray over quetiapine extended release, with relative risks ranging from 1. 462 to 1. 737 and from 1. 417 to 1. 838, respectively (all p < 0. 05). Treatment with esketamine nasal spray shortened time to first and confirmed remission (hazard ratio: 1. 711 [95% confidence interval 1. 402, 2. 087], p < 0. 001; 1. 658 [1. 337, 2. 055], p < 0. 001). Conclusion Esketamine nasal spray consistently demonstrated significant superiority over quetiapine extended release using all pre-specified definitions for remission and relapse. Sensitivity analyses supported the conclusions of the primary ESCAPE-TRD analysis and demonstrated robustness of the results.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Esketamine nasal spray ; long-term treatment ; quetiapine extended release ; sensitivity analysis ; treatment resistant depression
Publicado en:	The British journal of psychiatry, Vol. 226, Num. 2 (January 2025) , p. 72-78, ISSN 1472-1465

DOI: 10.1192/bjp.2024.124
PMID: 39618237

7 p, 543.8 KB

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