Use of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression in Routine Practice: A Real-World French Study.
Ludovic Samalin, Lila Mekaoui, Maud Rothärmel, Anne Sauvaget, Clotilde Wicart, Julien Dupin, Vanessa Cohignac, Émeline Gaudré-Wattinne
Depression and Anxiety 2024 DOI: 10.1155/2024/7262794 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational cohort Peer reviewed |
|---|---|
| Sample size | 157 |
| Population | French patients aged 65 or younger with treatment-resistant depression |
| Intervention | Esketamine nasal spray |
| Duration | 12-month follow-up |
| Topics | Depression Esketamine |
| Keywords | Mental health Ketamine therapy Medical breakthrough |
| Citations | 16 |
| Key findings | Esketamine nasal spray showed real-world effectiveness and safety consistent with previous trials, with 40% response and 20% remission at one month, but 80% discontinued treatment over 12 months. |
Abstract
The efficacy and safety of esketamine nasal spray (ESK) were established in registration trials in patients with treatment-resistant depression (TRD). This French real-world study aimed to describe the treatment patterns, effectiveness, and safety of ESK in TRD patients over a 12-month follow-up. This study used secondary data from patient files of hospital-based psychiatrists and started during the first French patient early access to ESK. The response and remission rates with ESK were analyzed using the total score of the Montgomery-Åsberg Depression Rating Scale (MADRS). The time to first treatment response and work resumption were described (Kaplan-Meier method). Adverse events (AEs) were analyzed. Prior to ESK initiation, the 157 analyzed patients (age ≤ 65 years, 82.8%; female, 66.2%) had depression for 10.5 years (median, IQR, 4.2-21.2) and received a median of 6 (3-8) previous treatment lines. At ESK initiation, the mean ± SD total MADRS score was 32.1 ± 7.7. At that time, ESK was combined with antidepressants (93.6% of patients; SNRI, 65.0%; SSRI, 57.3%) and/or other potentiation strategy (63.1%; atypical antipsychotics, 36.3%; lithium, 25.6%; antiepileptics, 21.7%). During the 12-month follow-up, 125 patients (79.6%) discontinued ESK. The median duration of ESK treatment was 19.4 weeks (IQR, 4.4-40.1). At 1 month after ESK initiation, 40.2% of still treated patients met criteria for clinical response and 19.7% for remission (median time to response, 5.7 weeks; 95% CI (4.1-8.4)). 82.6% of active patients were on sick leave at ESK initiation; the work resumption rate was 24% (13%-40%) 12 weeks later. AEs were reported in 68.6% of patients, serious AEs in 17.2%, and AEs leading to ESK discontinuation in 14.6%. These real-world effectiveness and safety data were consistent with findings from previous clinical trials, describing the real-life clinical experience of patients receiving ESK and confirming that ESK has its place in therapy for the treatment of TRD.
Comparable studies
Other observational and cohort studies on esketamine for depression, most cited first.
Citations in the library
Cited by 12
- Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. The International Journal of Neuropsychopharmacology June 6, 2025
- A Real-World Study on the Use, Effectiveness, and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression: INTEGRATE Study. Advances in Therapy May 1, 2025
- Intranasal esketamine: real-world clinical practice in treatment-resistant depression and factors associated with treatment response. BMC Psychiatry March 17, 2026
- Sustained effectiveness and safety of esketamine for major depressive disorder: a target trial simulation of real-world data. Translational Psychiatry April 10, 2026
- Effectiveness of intranasal esketamine in the treatment of patients with treatment-resistant depression: an observational study based on data collected in a Spravato treatment program at the Institute of Living, Hartford, CT. Psychopharmacology February 2, 2026
and 7 more in the library
Cites 16
- Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study American Journal of Psychiatry May 21, 2019
- Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression JAMA Psychiatry June 5, 2019
- Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) The International Journal of Neuropsychopharmacology July 9, 2019
- Management of Treatment-Resistant Depression: Challenges and Strategies Neuropsychiatric Disease and Treatment 2020
- Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression The Journal of Clinical Psychiatry April 20, 2020
and 11 more in the library