Maina Giuseppe, Adami Marina, Ascione Giuseppe, Bondi Emi, De Berardis Domenico, Delmonte Dario, Maffezzoli Silvia, Martinotti Giovanni, Nivoli Alessandra, Ottavianelli Elena, Fagiolini Andrea
Department of Neuroscience "Rita Levi Montalcini", University of Turin, Turin, Italy.
Psychiatric Unit, San Luigi Gonzaga University Hospital, Orbassano, Turin, Italy.
Ann Gen Psychiatry. 2023 Nov 23;22(1):48. doi: 10.1186/s12991-023-00478-7.
Treatment-resistant depression (TRD) is defined by the European Medicines Agency as a lack of clinically meaningful improvement after treatment, with at least two different antidepressants. Individual, familiar, and socio-economic burden of TRD is huge. Given the lack of clear guidelines, the large variability of TRD approaches across different countries and the availability of new medications to meet the need of effective and rapid acting therapeutic strategies, it is important to understand the consensus regarding the clinical characteristics and treatment pathways of patients with TRD in Italian routine clinical practice, particularly in view of the recent availability of esketamine nasal spray.
A Delphi questionnaire with 17 statements (with a 7 points Likert scale for agreement) was administered via a customized web-based platform to Italian psychiatrists with at least 5 years of experience and specific expertise in the field of depression. In the second-round physicians were asked to answer the same statements considering the interquartile range of each question as an index of their colleagues' responses. Stata 16.1 software was used for the analyses.
Sixty panellists, representative of the Italian territory, answered the questionnaire at the first round. For 8/17 statements more than 75% of panellists reached agreement and a high consensus as they assigned similar scores; for 4 statements the panellists assigned similar scores but in the middle of the Likert scale showing a moderate agreement with the statement, while for 5 statements there was indecision in the agreement and low consensus with the statement.
This Delphi Panel showed that there is a wide heterogeneity in Italy in the management of TRD patients, and a compelling need of standardised strategies and treatments specifically approved for TRD. A high level of consensus and agreement was obtained about the importance of adding lithium and/or antipsychotics as augmentation therapies and in the meantime about the need for long-term maintenance therapy. A high level of consensus and agreement was equally reached for the identification of esketamine nasal spray as the best option for TRD patients and for the possibility to administrate without difficulties esketamine in a community outpatient setting, highlighting the benefit of an appropriate educational support for patients.
欧洲药品管理局将难治性抑郁症（TRD）定义为在使用至少两种不同的抗抑郁药治疗后，临床上未出现有意义的改善。TRD给个人、家庭和社会经济带来的负担巨大。鉴于缺乏明确的指南，不同国家TRD治疗方法差异很大，且有新药物可满足有效和快速起效治疗策略的需求，了解意大利常规临床实践中TRD患者的临床特征和治疗途径的共识很重要，特别是考虑到最近艾氯胺酮鼻喷雾剂的可用性。
通过定制的基于网络的平台，向具有至少5年抑郁症领域经验和专业知识的意大利精神科医生发放了一份包含17条陈述（采用7点李克特量表表示同意程度）的德尔菲问卷。在第二轮中，要求医生根据每个问题的四分位间距作为其同事回答的指标来回答相同的陈述。使用Stata 16.1软件进行分析。
60名代表意大利不同地区的小组成员在第一轮回答了问卷。对于17条陈述中的8条，超过75%的小组成员达成了一致，并且由于他们给出了相似的分数，因此达成了高度共识；对于4条陈述，小组成员给出了相似的分数，但在李克特量表的中间位置，表明对该陈述有中等程度的认同，而对于5条陈述，在认同方面存在犹豫不决，对该陈述的共识较低。
该德尔菲小组表明，意大利在TRD患者的管理方面存在很大的异质性，迫切需要专门针对TRD的标准化策略和治疗方法。在将锂盐和/或抗精神病药物作为增效疗法的重要性以及同时进行长期维持治疗的必要性方面，达成了高度的共识。在将艾氯胺酮鼻喷雾剂确定为TRD患者的最佳选择以及在社区门诊环境中无困难地使用艾氯胺酮的可能性方面，也同样达成了高度的共识，突出了为患者提供适当教育支持的益处。
