Gutiérrez-Rojas Luis, Vendrell-Serres Julia, Ramos-Quiroga J Antoni, Etxeandia-Pradera Jon Iñaki, Aguilar Eduardo, De Santiago-Díaz Ana Isabel, Hernández-Huerta Daniel, Tordera Vicente, Vázquez-Ventoso Carlos, Bolívar Moisés, Abril Asunción, Catalán-Barragán Rubén, García-Jiménez Jesús
Department of Psychiatry and Neurosciences Research Group (CTS-549), Institute of Neurosciences, University of Granada, Granada, Spain.
Psychiatry Service, Hospital Clínico San Cecilio, Granada, Spain.
J Psychopharmacol. 2025 Jan;39(1):38-48. doi: 10.1177/02698811241267837. Epub 2024 Aug 7.
Treatment-resistant depression (TRD) is defined as the failure of at least two antidepressants in adequate doses and timing during a major depressive episode. Esketamine intranasal (ESK-IN) has been approved by the Food and Drug Administration and the European Medicines Agency for the treatment of TRD in combination with other antidepressants.
To assess the effectiveness and tolerability of a sample of TRD patients who received treatment with ESK-IN as part of the compassionate use program.
A retrospective, observational study was carried out on patients with a diagnosis of TRD enrolled in the early access program of ESK-IN in nine centers. Effectiveness was assessed with the Montgomery-Asberg depression rating scale (MADRS) at four time points: baseline, 28, 90, and 180 days of treatment.
The sample included 71 patients (70% women) with a mean baseline MADRS score of 38.27 ± 5.9 and total or partial work disability rates of 85%. ESK-IN treatment was associated with a statistically and clinically significant reduction in the severity of depressive symptoms at all time points assessed. The presence of side effects was common but the majority were mild in severity and resolved after the observation period. Those patients who received psychotherapy in combination with ESK-IN showed a significantly lower MADRS score at 90 and 180 days than those patients who did not undergo psychotherapy.
ESK-IN has proven to be effective and safe in a clinical sample of patients with severe TRD. To optimize clinical outcomes, the pharmacological treatment for TRD should always be integrated into a comprehensive therapeutic plan that encompasses strategies such as psychotherapy, social support, and family interventions.
难治性抑郁症（TRD）的定义是在一次重度抑郁发作期间，至少两种抗抑郁药物在足够剂量和疗程下治疗失败。艾氯胺酮鼻内给药（ESK-IN）已获得美国食品药品监督管理局和欧洲药品管理局批准，可与其他抗抑郁药物联合用于治疗TRD。
评估作为同情用药计划一部分接受ESK-IN治疗的TRD患者样本的有效性和耐受性。
对九个中心参加ESK-IN早期准入计划的TRD诊断患者进行了一项回顾性观察研究。在四个时间点使用蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评估有效性：基线、治疗28天、90天和180天。
样本包括71名患者（70%为女性），平均基线MADRS评分为38.27±5.9，完全或部分工作残疾率为85%。在所有评估的时间点，ESK-IN治疗均与抑郁症状严重程度在统计学和临床上的显著降低相关。副作用很常见，但大多数严重程度较轻，在观察期后消失。接受ESK-IN联合心理治疗的患者在90天和180天时的MADRS评分显著低于未接受心理治疗的患者。
在重度TRD患者的临床样本中，ESK-IN已被证明是有效且安全的。为了优化临床结果，TRD的药物治疗应始终纳入一个综合治疗计划，该计划包括心理治疗、社会支持和家庭干预等策略。
