Esketamine nasal spray in patients with treatment-resistant depression: the real-world experience in the French cohort early-access programme.
Ludovic Samalin, Maud Rothärmel, Lila Mekaoui, Émeline Gaudré-Wattinne, Marie-Alix Codet, Sophie Bouju, Anne Sauvaget
International Journal of Psychiatry in Clinical Practice November 2022 DOI: 10.1080/13651501.2022.2030757 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational cohort study Peer reviewed |
|---|---|
| Sample size | 66 |
| Population | Adults with treatment-resistant depression in France, resistant to a mean of 4.2 previous antidepressants, 78.8% with severe major depressive episodes |
| Intervention | Esketamine |
| Duration | Median treatment duration of 30 days; ATUc ended approximately 6 months after initiation |
| Measures | Montgomery-Åsberg Depression Rating Scale (MADRS) |
| Topics | Depression Esketamine |
| Keywords | Antidepressant Real-world experience |
| Key findings | Among 46 analysed patients with treatment-resistant depression receiving esketamine, 22 (47.8%) achieved response and 17 (37.0%) achieved remission at least once, with a 31.6% probability of remission by Week 4. The authors report that safety and efficacy in this real-world setting were consistent with Phase 3 trials and that no new safety signals were identified. |
Abstract
To present the first real-world data of patients with treatment-resistant depression (TRD) treated with esketamine through a French cohort Temporary Authorisation for Use (ATUc) programme. In 2019, the French Health Authorities exceptionally granted the first ATUc in psychiatry for TRD patients. Clinical characteristics, safety and efficacy data were reported by physicians. The ATUc ended ∼6 months after initiation. The cohort (n = 66; median age 53.0 years; 62.1% female; 78.8% with severe major depressive episodes; resistance to a mean of 4.2 previous antidepressants) received esketamine treatment for a median of 30 days. Among 46 analysed patients, 22 (47.8%) achieved response (Montgomery-Åsberg Depression Rating Scale [MADRS] total score reduction ≥50.0%) and 17 (37.0%) achieved remission (MADRS total score of ≤12) at least once at a median of 18.5 (2.0-77.0) and 21.0 (2.0-46.0) days after initiation, respectively. By Week 4, patients had a 31.6% probability of achieving remission (Kaplan-Meier method). Sedation, somnolence, dizziness, hypertension, anxiety and dissociation were the most frequently reported (>10.0%) adverse events. No new safety signals were identified. Patient characteristics of this cohort demonstrate high-level treatment resistance. The safety and efficacy of esketamine in patients with TRD in real-world clinical practice were consistent with Phase 3 trials.Key pointsPatients with treatment-resistant depression (TRD) exceptionally received esketamine nasal spray ahead of its launch through a French cohort Temporary Authorisation for Use (ATUc) programme.The clinical characteristics of 66 adult patients with TRD included in this cohort demonstrated a high-level of resistance to conventional treatments at the time of treatment request prior to esketamine initiation.No new safety signals were observed with esketamine initiation during the ATUc period compared with the Phase 3 clinical trials.The safety and efficacy of esketamine in the real world remain consistent with that established in Phase 3 clinical trials.The data collected during this ATUc also provide the first real-world data on the management and practical use of esketamine in a hospital setting in France.
Comparable studies
Other observational and cohort studies on esketamine for depression, most cited first.
Citations in the library
Cited by 33
- Glutamatergic Modulators for Major Depression from Theory to Clinical Use. CNS Drugs November 1, 2024
- Nationwide consensus on the clinical management of treatment-resistant depression in Italy: a Delphi panel Annals of General Psychiatry November 26, 2023
- Holding on or letting go? Patient experiences of control, context, and care in oral esketamine treatment for treatment-resistant depression: A qualitative study. Frontiers in Psychiatry 2022
- Efficacy and Safety of Intranasal Esketamine in Patients With Treatment-Resistant Depression and Comorbid Chronic Post-traumatic Stress Disorder: Open-Label Single-Arm Pilot Study Frontiers in Psychiatry July 8, 2022
- Esketamine Treatment Trajectory of Patients with Treatment-Resistant Depression in the Mid and Long-Term Run: Data from REAL-ESK Study Group. Current Neuropharmacology 2025
and 28 more in the library
Cites 8
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- 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
- Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression The Journal of Clinical Psychiatry April 20, 2020
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