Esketamine nasal spray in patients with treatment-resistant depression: the real-world experience in the French cohort early-access programme

Objective 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. Methods 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 similar to 6 months after initiation. Results 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-angstrom sberg 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. Conclusions 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.