Esketamine Treatment Trajectory of Patients with Treatment-Resistant Depression in the Mid and Long-Term Run: Data from REAL-ESK Study Group.
Gianluca Rosso, Giacomo d'Andrea, Stefano Barlati, Marco Di Nicola, Ileana Andriola, Matteo Marcatili, Vassilis Martiadis, Miriam Olivola, Stefania Di Mauro, Gabriele Di Salvo, Pasquale De Fazio, Massimo Clerici, Bernardo Maria Dell'Osso, Antonio Vita, Giorgio Di Lorenzo, Mauro Pettorruso, Giovanni Martinotti, Giuseppe Maina
Current neuropharmacology January 1, 2025 DOI: 10.2174/011570159X337670241029062524 via PubMed
Summary
AI-generated from the abstractAmong patients with treatment-resistant depression who continued esketamine nasal spray for at least six months, 76.2% responded or achieved remission. Of those who had not responded by six months, a subset improved by twelve months. Side effects occurred in 71.8% of patients at six months, decreasing to 42% at twelve months; the most common were sedation and dissociation. Only two patients stopped treatment due to tolerability issues. The findings suggest esketamine is effective and safe for mid- to long-term treatment, with a novel observation of late clinical response in some patients. Results require confirmation in larger samples and longer observation periods.
Study at a glance
| Characteristics | Observational, retrospective, multicentric study Peer reviewed |
|---|---|
| Sample size | 63 |
| Population | Patients with treatment-resistant depression |
| Intervention | Esketamine Nasal Spray |
| Duration | 6-month and 12-month follow-up |
| Topics | Depression Esketamine |
| Keywords | Antidepressants Maintenance treatment Treatment outcome. |
| Citations | 23 |
| Key finding | 76.2% of patients who maintained esketamine nasal spray for at least six months were responders or remitters, and a subgroup of initial non-responders improved by twelve months. |
Abstract
Data on long-term treatment with Esketamine Nasal Spray (ESKNS) in real-world patients with treatment resistant depression (TRD) is scarce. The primary aim of the study is to evaluate the effectiveness and tolerability of ESK-NS treatment at 6 and 12-month follow-ups. This is part of an observational, retrospective, multicentric Italian study (REAL-ESK study). Subjects for the present study underwent psychiatric assessments after 6 and 12 months from the start of ESK-NS treatment. Repeated measures analysis of variance (ANOVA) was used to assess changes in continuous variables, such as scores on psychometric scales from baseline to follow-up time points. Of 63 patients who maintained ESK-NS treatment for at least 6 months, 48 were responders or remitters (76.2%). Among 15 non-responders at 6 months, 4 significantly improved at 12-month follow-up. At least one side effect was reported by 71.8% of subjects with a 6-month follow-up assessment. An overall reduction of side effects was noticed as treatment progressed (42% of patients who continued the treatment reported side effects at 12 months). The most common side effects were sedation (31.7%) and dissociation (28.6%) during ESK-NS sessions. Only 2 patients discontinued ESK-NS for tolerability reasons. The results support the effectiveness and safety of esketamine in the mid and long-term treatment of TRD patients. The late clinical response of a subgroup of patients represents a novel finding. Data needs to be confirmed in larger samples and longer observation periods.