Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■抗治疗性抑郁症（TRD）定义为在严重抑郁发作期间，至少两种抗抑郁药以足够的剂量和时机失败。鼻内使用Esketamine（ESK-IN）已被食品和药物管理局和欧洲药品管理局批准用于与其他抗抑郁药联合治疗TRD。
■评估接受ESK-IN治疗的TRD患者样本的有效性和耐受性作为同情使用计划的一部分。
■回顾，在9个中心的ESK-IN早期接入计划中纳入的诊断为TRD的患者中进行了观察性研究.在四个时间点使用Montgomery-Asberg抑郁量表（MADRS）评估有效性：基线，28、90和180天的治疗。
■样本包括71名患者（70％的女性），平均基线MADRS评分为38.27±5.9，总或部分工作残疾率为85％。在评估的所有时间点，ESK-IN治疗与抑郁症状严重程度的统计学和临床显着降低相关。副作用的存在很常见，但大多数严重程度较轻，在观察期后缓解。与未接受心理治疗的患者相比，接受心理治疗与ESK-IN联合治疗的患者在90天和180天时的MADRS评分显着降低。
■ESK-IN已被证明在严重TRD患者的临床样本中是有效和安全的。为了优化临床结果，TRD的药物治疗应始终纳入包括心理治疗等策略的综合治疗计划，社会支持,家庭干预。
■评估接受ESK-IN治疗的TRD患者样本的有效性和耐受性作为同情使用计划的一部分。
■回顾，在9个中心的ESK-IN早期接入计划中纳入的诊断为TRD的患者中进行了观察性研究.在四个时间点使用Montgomery-Asberg抑郁量表（MADRS）评估有效性：基线，28、90和180天的治疗。
■样本包括71名患者（70％的女性），平均基线MADRS评分为38.27±5.9，总或部分工作残疾率为85％。在评估的所有时间点，ESK-IN治疗与抑郁症状严重程度的统计学和临床显着降低相关。副作用的存在很常见，但大多数严重程度较轻，在观察期后缓解。与未接受心理治疗的患者相比，接受心理治疗与ESK-IN联合治疗的患者在90天和180天时的MADRS评分显着降低。
■ESK-IN已被证明在严重TRD患者的临床样本中是有效和安全的。为了优化临床结果，TRD的药物治疗应始终纳入包括心理治疗等策略的综合治疗计划，社会支持,家庭干预。
