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Publications

Journal Article Review Epublish

PubMed: 42682977 DOI: 10.1177/20451253261463652

Real-world clinical practice, effectiveness and safety of esketamine nasal spray in major depressive disorder patients: a French prospective cohort (ELLIPSE study).

Ther Adv Psychopharmacol 16:20451253261463652

Authors: Pierre-Michel Llorca, Anne Sauvaget, Emilie Olié, Lila Mékaoui, Ludovic Samalin, Maud Rothärmel, Anne-Laure Boitez, Julien Dupin, Clotilde Wicart, Emeline Gaudre-Wattinne, Hugo Lacour, Benjamin Grenier, Bernard Astruc, Bruno Falissard, Pierre de Maricourt

Affiliations

  • Department of Psychiatry, CHU Clermont-Ferrand, University of Clermont Auvergne, CNRS, Clermont Auvergne INP, Institute Pascal (UMR 6602), Clermont-Ferrand 63003, France.
  • Nantes Université, CHU Nantes, Movement-Interactions-Performance, MIP, UR 4334, Nantes, France.
  • Montpellier University Hospital, Lapeyronie Hospital, Psychiatric Emergency and Post Emergency Department, Pole Urgence, Montpellier, France.
  • Sainte Anne Hospital GHU Paris, Pôle Hospitalo-Universitaire Psychiatrie Paris 15, Psychiatry and Neurosciences, Paris, France.
  • Department of Psychiatry, CHU Clermont-Ferrand, University of Clermont Auvergne, CNRS, Clermont Auvergne INP, Institute Pascal (UMR 6602), Clermont-Ferrand, France.
  • Centre Hospitalier du Rouvray, Service Hospitalo-Universitaire de Psychiatrie, Centre d'Excellence Thérapeutique, Sotteville-lès-Rouen, France.
  • ICON for J&J Innovative Medicine, Issy-les-Moulineaux, France.
  • Medical Affairs, Janssen-Cilag, Issy-les-Moulineaux, France.
  • Heva, Lyon, France.
  • Medical Affairs, Les Toises - Psychiatry and Psychotherapy Center, Lausanne, Switzerland.
  • CESP, INSERM U1018, Paris-Saclay University, AP-HP, Villejuif, France.

Abstract

BACKGROUND

Major depressive disorder (MDD) is highly prevalent and associated with significant disability and mortality. Treatment-resistant depression (TRD), defined as inadequate response to ⩾2 antidepressant lines, remains a major therapeutic challenge. Esketamine nasal spray, approved in 2019 for TRD, demonstrated efficacy and safety in randomized trials, but real-world evidence remains limited.

OBJECTIVES

The ELLIPSE study aimed to describe patient characteristics, treatment patterns, and 12-month outcomes of esketamine in routine clinical practice in France.

DESIGN

ELLIPSE was a prospective, multicenter, observational cohort study including adults with unipolar MDD initiating esketamine between Dec 2021 and Jul 2023, followed for 12 months.

METHODS

Data were collected via standardized clinical assessments. Effectiveness was evaluated using the Montgomery-Åsberg Depression Rating Scale (MADRS). Response was defined as ⩾50% MADRS reduction; remission as MADRS ⩽ 10.

RESULTS

A total of 200 patients (mean age 46.6 years; 56.5% female) were enrolled; 97.5% met TRD criteria. Median esketamine exposure was 4.5 months. Mean MADRS decreased from 31.9 at baseline to 12.4 at month 12 (mean change -17.9; 95% CI: -21.6 to -14.2). Response and remission rates reached a plateau at month 2, where the response rate was 55.2% and the remission rate was 33.6%, maintained up to month 12. Adverse events (AEs) occurred in 65.7% of patients, most commonly dissociative states (28.0%) and transient blood pressure increases (11.6%).

CONCLUSION

This real-world study in patients with treatment-resistant depression, including those with comorbidities/prior suicide attempts, showed clinically relevant improvement from month 2, sustained through 12 months. Dissociative symptoms were the most frequent treatment-related AE.

MeSH

Depression, Safety, Depressive Disorder, Nasal Sprays, Therapeutics, Depressive Disorder, Major