Samalin Ludovic, Mekaoui Lila, De Maricourt Pierre, Sauvaget Anne, Codet Marie-Alix, Gaudré-Wattinne Émeline, Wicart Clotilde, Rothärmel Maud
CHU Clermont-Ferrand, Department of Psychiatry, University of Clermont Auvergne, CNRS, Clermont Auvergne INP, Institut Pascal (UMR 6602), Clermont-Ferrand, France.
GHU Paris - Psychiatry and Neurosciences, Clinique des maladies mentales et de l'encéphale, Sainte-Anne Hospital, Paris, France.
Int J Psychiatry Clin Pract. 2024 Jun;28(2):83-93. doi: 10.1080/13651501.2024.2398788. Epub 2024 Sep 2.
ESKALE is a French, multicentre, observational study of adults with treatment-resistant depression (TRD) treated with esketamine. This interim analysis describes baseline demographic and clinical characteristic evolution in patients included and treated from early access program to post-marketing launch.
Data were collected from medical records and included patient characteristics, disease history at esketamine initiation, use of neurostimulation, the patient's care pathway, and the number of antidepressant treatment lines prescribed prior to esketamine initiation. Descriptive statistics were used for each cohort: the early access program 'Temporary Authorisation for Use' (ATU), post-ATU, and post-launch cohorts.
The overall ESKALE cohort ( = 160 included; = 157 treated with esketamine; average age 49.0 years; 66.2% female) demonstrated moderate-to-severe depression according to clinical assessment and a mean Montgomery-Åsberg Depression Rating Scale score of 32.6 (8.0); however, severity, subtype, and comorbidities were heterogeneous across the cohorts. Earlier use of esketamine and prior to alternative treatments occurred during the later cohorts.
These findings demonstrated a high burden of TRD in these patients and that esketamine is used in TRD treatment regardless of their disease severity, subtype, or existing comorbidities. These results also suggest that esketamine is potentially a clinically useful alternative treatment, particularly with healthcare professionals gaining greater familiarity with and easier access to esketamine.
ESKALE是一项针对难治性抑郁症（TRD）成人患者使用艾氯胺酮进行治疗的法国多中心观察性研究。这项中期分析描述了从早期准入计划到上市后阶段纳入并接受治疗的患者的基线人口统计学和临床特征演变情况。
从病历中收集数据，包括患者特征、开始使用艾氯胺酮时的疾病史、神经刺激的使用情况、患者的治疗路径以及开始使用艾氯胺酮之前开具的抗抑郁治疗疗程数。对每个队列使用描述性统计：早期准入计划“临时使用授权”（ATU）队列、ATU后队列和上市后队列。
ESKALE总队列（n = 160例纳入；n = 157例接受艾氯胺酮治疗；平均年龄49.0岁；66.2%为女性）根据临床评估显示为中度至重度抑郁症，蒙哥马利-Åsberg抑郁量表平均评分为32.6（8.0）；然而，各队列之间的严重程度、亚型和合并症存在异质性。在后期队列中，艾氯胺酮的使用更早且在替代治疗之前。
这些发现表明这些患者中TRD负担较重，并且无论疾病严重程度、亚型或现有合并症如何，艾氯胺酮都用于TRD治疗。这些结果还表明，艾氯胺酮可能是一种临床上有用的替代治疗方法，特别是随着医疗保健专业人员对艾氯胺酮更加熟悉且更容易获得。
