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Patient reported outcomes of MDD patients treated with esketamine nasal spray in real world practice: the French ELLIPSE study

P.-M. Llorca, Ludovic Samalin, Emilie Olié, I. Rodriguez, Julien Dupin, Clotilde Wicart, Pierre Demaricourt

European Psychiatry June 1, 2026 DOI: 10.1192/j.eurpsy.2026.10194 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Prospective, multicenter, non-interventional observational study Peer reviewed
Sample size 200
Population Adults with major depressive disorder in France, most (97.5%) with treatment-resistant depression, enrolled across 31 sites
Intervention Esketamine nasal spray
Duration 12-month follow-up
Measures QIDS-SR16, QLDS, WPAI:D
Topics Depression Esketamine
Key findings Among 200 patients with major depressive disorder starting esketamine nasal spray, QIDS response rates increased to 37.7% at month 2 and 45.0% at month 3 before plateauing, while QLDS response reached 26.5% at month 2 in treated patients and WPAI:D work-impairment scores improved across all four domains in those still under treatment. The authors argue these patient-reported outcomes support esketamine's role in treatment-resistant depression.

Abstract

Introduction: Esketamine nasal spray (ESK) was approved in 2019 in Europe for adults with Treatment-Resistant Depression (TRD), defined as inadequate response to at least two different antidepressants during the current moderate to severe depressive episode

Objectives: To assess patient-reported outcomes related to symptomatology, quality of life, and occupational impairment over 12 months following ESK initiation in patients with Major Depressive Disorder (MDD)

Methods: ELLIPSE is a French, prospective, multicenter, non-interventional study describing MDD patients treated with ESK. Patient-reported outcomes were collected using QIDS-SR16, QLDS, and WPAI:D questionnaires throughout the 12-month follow-up (Baseline, D8, M1, M2, M3, M6, M9, M12).

Results: A total of 200 MDD patients (including 195 [97.5%] treatment resistant patients) were enrolled across 31 sites. Among them, 108 (54.0%) were employed at baseline, including 79 on sick leave. The remaining 92 patients had no occupation at baseline, and 50 (25.0%) cited the current depressive episode as the reason, while 30 (15.0%) were retired. QIDS response rates (improvement from baseline ≥ 50% or score ≤ 5) in patients treated with ESK increased to 37.7% at Month 2 (M2) and 45.0% at Month 3 (M3), then plateaued (Figure 1). QLDS response (improvement from baseline ≥ 8, (Rozjabek et al. 2022)) followed a similar trend, reaching 26.5% at M2 in patients undertreatment, with sustained response over the follow-up in both the total population and the patients still under treatment (Figure 2). WPAI:D scores showed consistent improvement across all four domains in patients still under treatment at the visit (Figure 3). Image 1: Image 1: Long description. Image 2: Image 2: Long description. Image 3: Image 3: Long description.

Conclusions: ELLIPSE is the first large-scale, real-world study in France to evaluate esketamine in MDD, offering a 360-degree view of the patient evaluation. By integrating patient-reported outcomes on depressive symptoms, quality of life, and occupational functioning, the study highlights the central role of the patient perspective in assessing treatment effectiveness. These findings reinforce the relevance of ESK in the therapeutic arsenal for TRD. Disclosure of Interest: P.-M. Llorca Consultant of: Johnson&Johnson consultant, L. Samalin Consultant of: Johnson&Johnson consultant, E. Olié Consultant of: Johnson&Johnson consultant, I. Rodriguez Employee of: Johnson&Johnson employee, J. Dupin Employee of: Johnson&Johnson employee, C. Wicart Employee of: Johnson&Johnson employee, P. Demaricourt Consultant of: Johnson&Johnson consultant

Comparable studies

Other observational and cohort studies on esketamine for depression, most cited first.

Study Year Design Participants
Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment‐resistant depression Patients with treatment-resistant bipolar depression (B-TRD) and unipolar... 2023 Observational cohort n = 70
Comparative Effectiveness of Intravenous Ketamine and Intranasal Esketamine in Clinical Practice Among Patients With Treatment-Refractory Depression: An Observational Study. Adults with treatment-resistant depression 2023 Observational study n = 62
Predicting outcome with Intranasal Esketamine treatment: A machine-learning, three-month study in Treatment-Resistant Depression (ESK-LEARNING) Treatment-resistant depression patients 2023 Retrospective, multicentric, real-world study n = 149
Esketamine in treatment-resistant depression patients comorbid with substance-use disorder: A viewpoint on its safety and effectiveness in a subsample of patients from the REAL-ESK study Patients with treatment-resistant depression and a substance use disorder 2023 Observational, retrospective, multicentre study n = 26
Rapid infusion of esketamine for unipolar and bipolar depression: a retrospective chart review Patients with treatment-resistant depression and bipolar depression meeting DSM-IV-TR... 2017 Retrospective observational study n = 27

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