Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Corresponding Author: Chirag M. Vyas, MBBS, MPH, Massachusetts General Hospital, One Bowdoin Sq, 7th Floor, Boston, MA 02114 (
J Clin Psychiatry. 2023 Jun 26;84(4):22m14629. doi: 10.4088/JCP.22m14629.
To test vitamin D and omega-3 fatty acids (omega-3s) for late-life depression prevention under the National Academy of Medicine framework for indicated (targeting subthreshold depression) and selective (targeting presence of high-risk factors) prevention. The VITamin D and OmegA-3 TriaL (VITAL) is a 2 × 2 factorial trial of vitamin D (2,000 IU/d) and/or omega-3s (1 g/d) for cardiovascular and cancer prevention (enrollment: November 2011-March 2014; end date: December 31, 2017). In this targeted prevention study, we included 720 VITAL clinical sub-cohort participants who completed neurobehavioral assessments at baseline and 2 years (91.9% retention). High-risk factors were subthreshold or clinical anxiety, impaired activities of daily living, physical/functional limitation, medical comorbidity, cognitive impairment, caregiving burden, problem drinking, and low psychosocial support. Coprimary outcomes were incident major depressive disorder (MDD), adjudicated using (, Fourth Edition), and change in mood (Patient Health Questionnaire-9 [PHQ-9]). We used exact tests to determine treatment effects on MDD incidence and repeated-measures models to determine treatment effects on PHQ-9. A total of 11.1% had subthreshold depression, 60.8% had ≥ 1 high-risk factor, MDD incidence was 4.7% (5.1% among completers), and mean PHQ-9 score change was 0.02 points. Among those with subthreshold depression, the MDD risk ratio (95% confidence interval) was 0.36 (0.06 to 1.28) for vitamin D and 0.85 (0.25 to 2.92) for omega-3s, compared to placebo; results were also null among those with ≥ 1 high-risk factor (vitamin D vs placebo: 0.63 [0.25 to 1.53]; omega-3s vs placebo: 1.08 [0.46 to 2.71]). There were no significant differences in PHQ-9 score change comparing either supplement with placebo. Neither vitamin D nor omega-3s showed benefits for indicated and selective prevention of late-life depression; statistical power was limited. ClinicalTrials.gov identifier: NCT01696435.
在国家医学科学院针对亚临床（针对阈下抑郁）和选择性（针对存在高危因素）预防的框架下，测试维生素 D 和欧米伽-3 脂肪酸（ω-3s）用于预防晚年抑郁症。VITamin D 和 OmegA-3 TriaL（VITAL）是一项针对心血管疾病和癌症预防的维生素 D（2000IU/d）和/或 ω-3s（1g/d）的 2×2 析因试验（入组时间：2011 年 11 月至 2014 年 3 月；截止日期：2017 年 12 月 31 日）。在这项针对性预防研究中，我们纳入了 720 名完成基线和 2 年神经行为评估的 VITAL 临床亚队列参与者（保留率为 91.9%）。高危因素包括阈下或临床焦虑、日常生活活动受损、身体/功能受限、合并症、认知障碍、照顾负担、饮酒问题和低社会心理支持。主要结局是新发重度抑郁症（MDD），采用《精神障碍诊断与统计手册》（第四版）进行判定，并评估心境变化（患者健康问卷-9[PHQ-9]）。我们使用确切检验来确定治疗对 MDD 发病率的影响，以及重复测量模型来确定治疗对 PHQ-9 的影响。11.1%的参与者存在阈下抑郁，60.8%的参与者存在≥1 个高危因素，MDD 的发病率为 4.7%（完成者中的发病率为 5.1%），PHQ-9 评分的平均变化为 0.02 分。在存在阈下抑郁的患者中，维生素 D 的 MDD 风险比（95%置信区间）为 0.36（0.06 至 1.28），ω-3s 为 0.85（0.25 至 2.92），与安慰剂相比；对于存在≥1 个高危因素的患者，结果也为阴性（维生素 D 与安慰剂相比：0.63[0.25 至 1.53]；ω-3s 与安慰剂相比：1.08[0.46 至 2.71]）。与安慰剂相比，两种补充剂在 PHQ-9 评分变化方面均无显著差异。维生素 D 和 ω-3s 均未显示出对晚年抑郁症的有针对性和选择性预防的益处；统计效能有限。临床试验.gov 标识符：NCT01696435。
