Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Trials. 2020 Aug 3;21(1):695. doi: 10.1186/s13063-020-04460-6.
Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on studies to date, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after 6 months of follow up will be the primary outcome.
This is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow up. At each time point, the following validated rating scales will be administered: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled.
This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants' data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards.
Clinicaltrials.gov: NCT03779789 , Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018-001444-66.
Protocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021.
抑郁症在老年人中是一种高发疾病，严重影响生活质量、预期寿命和医疗结果。选择性 5-羟色胺再摄取抑制剂（SSRIs）是治疗这种疾病最常用的药物，虽然通常安全，但也不能忽视其耐受性问题。文拉法辛是一种具有新型作用机制的抗抑郁药。根据目前的研究，它在老年人中可能具有有前景的耐受性特征，因为它不会对精神运动或认知表现产生不利影响，也不会改变心血管和内分泌参数。本研究旨在评估文拉法辛与 SSRIs 相比在老年抑郁症患者中的耐受性特征，SSRIs 作为一个单一的治疗组。6 个月随访后因不良反应退出治疗的参与者比例将是主要结局。
这是一项由意大利药品管理局（AIFA - Agenzia Italiana del Farmaco）资助的实用、多中心、开放标签、平行组、优效性、随机试验。13 家意大利社区精神病服务机构将在 12 个月内连续招募患有重度抑郁症发作的老年参与者。参与者将在基线和随访 1、3 和 6 个月时进行评估。在每个时间点，将使用以下经过验证的评分量表进行评估：蒙哥马利-阿斯伯格抑郁评定量表（MADRS）、抗抑郁药副作用检查表（ASEC）、欧洲五维健康量表（EQ-5D）、简短Blessed 测试（SBT）和 Charlson 年龄合并症指数（CACI）。结局评估者和统计人员将对治疗分配进行盲法评估。共纳入 358 名参与者（每组 179 名）。
本研究将完全遵守 ICH E6 指导原则下的良好临床实践。参与者的数据将根据欧洲数据保护条例 2016/679 进行管理和保护。外部伦理咨询委员会将有助于保证高标准的伦理原则。
Clinicaltrials.gov：NCT03779789，注册于 2018 年 12 月 19 日。提交于 2018 年 12 月 19 日。EudraCT 编号：2018-001444-66。
方案版本 1.5；2018 年 6 月 9 日。招募于 2019 年 2 月开始，正在进行中。预计于 2021 年 9 月 30 日结束。
