A Real-World Study on the Use, Effectiveness, and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression: INTEGRATE Study.
Patricio Molero, Angela Ibañez, Javier de Diego-Adeliño, J Antoni Ramos-Quiroga, Marta García Dorado, Paola M López Rengel, Pilar A Saiz
Advances in therapy May 1, 2025 DOI: 10.1007/s12325-025-03149-z via PubMed
Summary
AI-generated from the abstractIn a real-world Spanish study of 189 adults with treatment-resistant depression, esketamine nasal spray led to response or remission in 80.4% of patients during the induction phase and 90% during the maintenance phase. Remission rates rose from 9.5% in induction to 38.3% in maintenance. Over a quarter of patients (28.0%) reported symptom improvement within 24 hours. Most adverse events were mild and decreased over time, especially in the first four weeks. The findings suggest esketamine nasal spray is an effective and safe option for treatment-resistant depression.
Study at a glance
| Characteristics | Observational, cross-sectional, retrospective study Peer reviewed |
|---|---|
| Sample size | 196 |
| Population | Adults aged 18-74 years with treatment-resistant depression in Spain |
| Intervention | Esketamine nasal spray |
| Topics | Depression Esketamine |
| Keywords | Mental health breakthrough Esketamine therapy Observational study Real-world evidence |
| Citations | 8 |
| Key finding | Esketamine nasal spray produced response or remission in 80.4% of patients during the induction phase and 90% during the maintenance phase, with most adverse events being mild and decreasing over time. |
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.