Psychiatric Centre Copenhagen, Copenhagen Affective Disorder Research Centre (CADIC), Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, Denmark
Faculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
BMJ Open. 2024 Nov 18;14(11):e084105. doi: 10.1136/bmjopen-2024-084105.
Accumulating data support the association between increased inflammation and bipolar disorder (BD), and preliminary data suggest that augmentation with low-dose aspirin (LDA) may protect against the onset and deterioration of BD via anti-inflammatory pathways. The A-bipolar randomised controlled trial (RCT) aims to investigate whether adding LDA to standard treatment improves day-to-day mood instability (MI) in BD.
A two-arm, triple-blind, parallel-group, superiority RCT including 250 patients with newly diagnosed BD treated at the Copenhagen Affective Disorder Clinic, Denmark. Participants are randomised 1:1 to either 150 mg of acetylsalicylic acid daily (LDA) or a placebo for six months in addition to their regular treatment. Mood instability, calculated from daily smartphone-based mood evaluations, is the primary outcome measure due to its internal validity as a real-life measure for patients and external validity as it reflects patients' illness severity and functioning. Analyses will be conducted as intention-to-treat analyses using a linear mixed model including time (categorical) and the time-treatment interaction as fixed effects and with an unstructured covariance pattern to account for repeated measurements on each study participant. The trial is Good Clinical Practice monitored.
The Danish Research Ethics Committee (H-21014515) and the data agency, Capital Region of Copenhagen (P-2021-576) approved the trial. Results will be published in peer-reviewed journals.
NCT05035316.
越来越多的数据支持炎症与双相情感障碍（BD）之间的关联，初步数据表明，低剂量阿司匹林（LDA）的增效治疗可能通过抗炎途径预防 BD 的发作和恶化。A-双相随机对照试验（RCT）旨在研究在标准治疗中添加 LDA 是否能改善 BD 患者的日常情绪不稳定（MI）。
这是一项包括 250 名新诊断为 BD 的患者的双臂、三盲、平行组、优效性 RCT，患者在丹麦哥本哈根情感障碍诊所接受治疗。参与者按照 1:1 的比例随机分配，每天服用 150 毫克乙酰水杨酸（LDA）或安慰剂，为期 6 个月，同时接受常规治疗。情绪不稳定是通过基于智能手机的日常情绪评估计算得出的，是主要的结局测量指标，因为它作为患者的真实生活测量具有内部有效性，并且反映了患者的疾病严重程度和功能。分析将作为意向治疗分析进行，使用线性混合模型，包括时间（分类）和时间-治疗交互作为固定效应，采用非结构协方差模式来解释每个研究参与者的重复测量。该试验受到良好临床实践的监测。
丹麦研究伦理委员会（H-21014515）和数据机构哥本哈根首都大区（P-2021-576）批准了该试验。结果将发表在同行评议的期刊上。
NCT05035316。
