Cockayne Nicole L, Duffy Shantel L, Bonomally Rosalind, English Amelia, Amminger Paul G, Mackinnon Andrew, Christensen Helen M, Naismith Sharon L, Hickie Ian B
Healthy Brain Ageing Program, Brain and Mind Research Institute, University of Sydney, 94 Mallett Street, Camperdown, NSW, 2050, Australia.
Orygen - The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Locked Bag 10, Parkville, VIC, 3052, Australia.
Trials. 2015 Jun 3;16:247. doi: 10.1186/s13063-015-0762-6.
Late-life depression is associated with high rates of morbidity, premature mortality, disability, functional decline, caregiver burden and increased health care costs. While clinical and public health approaches are focused on prevention or early intervention strategies, the ideal method of intervention remains unclear. No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older populations at risk of depression.
METHODS/DESIGN: Subjects with previously reported sub-threshold depressive symptoms, aged 60 to 74 years, will be screened to participate in a single-centre, double-blind, randomised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride, compared with matching placebo. Subjects will be excluded if they have current depression or suicide ideation; are taking antidepressants or any supplement containing omega-3 fatty acid; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease, neurological disease, significant psychiatric disease (other than depression) or neurodegenerative disease. The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events. At three months, subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes. Additionally, proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions. The trial will be conducted in urban New South Wales, Australia, and will recruit a community-based sample of 450 adults. Using intention-to-treat methods, the primary endpoint is an absence of clinically relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition.
The current health, social and economic costs of late-life depression make prevention imperative from a public health perspective. This innovative trial aims to address the long-neglected area of prevention of depression in older adults. The interventions are targeted to the pathophysiology of disease, and regardless of the effect size of treatment, the outcomes will offer major scientific advances regarding the neurobiological action of these agents. The main results are expected to be available in 2017.
Australian and New Zealand Clinical Trials Registry ACTRN12610000032055 (12 January 2010).
老年期抑郁症与高发病率、过早死亡、残疾、功能衰退、照料者负担以及医疗费用增加相关。虽然临床和公共卫生方法侧重于预防或早期干预策略，但理想的干预方法仍不明确。尚无研究着手评估神经生物学药物在预防有抑郁症风险的老年人群抑郁症状方面的作用。
方法/设计：对年龄在60至74岁、先前报告有阈下抑郁症状的受试者进行筛查，以参与一项单中心、双盲、随机对照试验，该试验有三个平行组，分别涉及补充ω-3脂肪酸或盐酸舍曲林，并与匹配的安慰剂进行比较。如果受试者目前患有抑郁症或有自杀意念；正在服用抗抑郁药或任何含ω-3脂肪酸的补充剂；或有中风或其他严重脑血管或心血管疾病、神经系统疾病、重大精神疾病（抑郁症除外）或神经退行性疾病的既往史，则将其排除。该试验将包括一个为期12个月的治疗阶段，并在3个月和12个月时进行随访以评估结局事件。在3个月时，受试者将接受结构神经影像学检查，以评估对抑郁症状的治疗效果是否与脑变化相关。此外，质子光谱技术将用于获取干预措施生物学效应的脑成像标记物。该试验将在澳大利亚新南威尔士州的城市进行，将招募450名基于社区的成年人样本。采用意向性分析方法，主要终点是在12个月时，ω-3脂肪酸和舍曲林干预组与安慰剂组之间不存在临床相关的抑郁评分。
从公共卫生角度来看，老年期抑郁症当前的健康、社会和经济成本使得预防势在必行。这项创新性试验旨在解决长期被忽视的老年人抑郁症预防领域的问题。这些干预措施针对疾病的病理生理学，无论治疗效果大小，其结果都将在这些药物的神经生物学作用方面带来重大科学进展。主要结果预计将于2017年公布。
澳大利亚和新西兰临床试验注册中心ACTRN12610000032055（2010年1月12日）。
