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 01, 2025
Source: PubMed
Summary
A breakthrough nasal spray treatment offers new hope for people with hard-to-treat depression, with 80% of patients showing significant improvement. Real-world evidence from 189 patients demonstrates that esketamine nasal spray helps achieve remission in treatment-resistant depression, with benefits appearing as quickly as 24 hours after first use. Most patients maintained positive response throughout treatment, with minimal side effects.
Abstract
The INTEGRATE study aimed to provide information on the use, effectiveness, and safety of esketamine nasal spray (ESK-NS) for the treatment of treatment-resistant depression (TRD) in real-world practice in Spain. This was an observational, cross-sectional, retrospective study conducted in adults aged 18-74 years who met the criteria for TRD. The weekly impact of ESK-NS on depressive symptoms was evaluated by clinical judgment using four categories (nonresponse, response, remission, not available). The onset of action 24 h after administration was also evaluated. Information on adverse events was collected from the medical records. We included 196 patients, of whom 189 were considered evaluable; the mean (SD) number of previous episodes was 3.7 (3.0). According to the investigator's judgment, 152 (80.4%) of 189 patients were in response or remission in the induction phase, and 54 (90%) of 60 during the maintenance phase. The proportions of patients in remission were 9.5%, 18.7%, and 38.3% during the induction, optimization, and maintenance phases, respectively. Fifty-three (28.0%) patients experienced an improvement in depressive symptoms within the first 24 h after the first administration of ESK-NS. Most adverse events reported with ESK-NS were mild and did not require any action with the study drug; the number of adverse events decreased over time, especially during the first 4 weeks. Consistent with the available evidence, the results of this study indicate that ESK-NS is an effective and safe option to consider within the therapeutic algorithm for TRD.