Molero Patricio, Ibañez Angela, de Diego-Adeliño Javier, Ramos-Quiroga J Antoni, García Dorado Marta, López Rengel Paola M, Saiz Pilar A
Department of Psychiatry, Clínica Universidad de Navarra. Navarra Institute for Health Research (IdiSNA), Pamplona, Spain.
Department of Psychiatry, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.
Adv Ther. 2025 May;42(5):2335-2353. doi: 10.1007/s12325-025-03149-z. Epub 2025 Mar 19.
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.
INTEGRATE研究旨在提供关于艾氯胺酮鼻喷雾剂（ESK-NS）在西班牙实际临床中用于治疗难治性抑郁症（TRD）的使用情况、有效性和安全性的信息。
这是一项针对年龄在18至74岁、符合TRD标准的成年人进行的观察性、横断面、回顾性研究。通过临床判断使用四个类别（无反应、有反应、缓解、数据不可用）评估ESK-NS对抑郁症状的每周影响。还评估了给药后24小时的起效情况。从病历中收集不良事件信息。
我们纳入了196例患者，其中189例被认为可评估；既往发作的平均（标准差）次数为3.7（3.0）次。根据研究者的判断，189例患者中有152例（80.4%）在诱导期有反应或缓解，60例患者中有54例（90%）在维持期有反应或缓解。诱导期、优化期和维持期缓解患者的比例分别为9.5%、18.7%和38.3%。53例（28.0%）患者在首次使用ESK-NS后的头24小时内抑郁症状有所改善。ESK-NS报告的大多数不良事件为轻度，无需对研究药物采取任何措施；不良事件的数量随时间减少，尤其是在最初4周内。
与现有证据一致，本研究结果表明，ESK-NS是TRD治疗方案中一种有效且安全可考虑的选择。
