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, Josep Antoni Ramos‐quiroga, Marta García Dorado, Paola M López Rengel, Pilar A. Sáiz
Advances in Therapy May 1, 2025 DOI: 10.1007/s12325-025-03149-z (opens in new tab)
Study at a glance
AI-extracted from the abstract| 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 Remission Response Depression treatment Clinical outcomes |
| Citations | 8 |
| Key findings | 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.
Comparable studies
Other cross-sectional and survey studies on esketamine for depression, most cited first.
Citations in the library
Cited by 7
- Treatment-resistant depression and intranasal esketamine: Spanish clinical consensus on practical aspects The European Journal of Psychiatry May 2, 2025
- Systematic review and meta-analysis of intranasal esketamine for treatment-resistant depression: Evidence from real-world studies. Journal of Affective Disorders January 28, 2026
- Intranasal esketamine for treatment-resistant depression: real-world effectiveness in electroconvulsive therapy non-responders The European Journal of Psychiatry March 7, 2026
- Real-world clinical practice, effectiveness and safety of esketamine nasal spray in major depressive disorder patients: a French prospective cohort (ELLIPSE study) Therapeutic Advances in Psychopharmacology August 1, 2026
- Comparative Efficacy of Esketamine Nasal Spray Versus Quetiapine Extended Release as Adjunctive Treatments for Treatment-Resistant Depression: A Systematic Review Annals of Clinical Psychiatry July 29, 2026
and 2 more in the library
Cites 14
- 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
- Role of BDNF in the pathophysiology and treatment of depression: Activity‐dependent effects distinguish rapid‐acting antidepressants European Journal of Neuroscience December 6, 2019
- Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression The Journal of Clinical Psychiatry April 20, 2020
and 9 more in the library