No Effect of Low‐Dose Aspirin Versus Placebo as Add‐On Treatment in Bipolar Disorder—Results From a Randomised Controlled Trial (the A‐Bipolar RCT )

作者：Caroline Fussing Bruun, Helle B. Krogh, Jeff Zarp Petersen, Julie Ravneberg Stokholm, Julie Lyng Forman, Kamilla Woznica Miskowiak, Annamaria Giraldi, Maj Vinberg, Maria Faurholt‐Jepsen, Lars Vedel Kessing · 发表于：Acta Psychiatrica Scandinavica · 年份：2025 · DOI：10.1111/acps.70055 · 被引用次数：3 · 研究领域：Bipolar Disorder and Treatment、Electroconvulsive Therapy Studies、Schizophrenia research and treatment

INTRODUCTION: Robust evidence associates immunoinflammatory dysfunction and bipolar disorder (BD), with immune dysregulation present in patients newly diagnosed with BD. This suggests that anti-inflammatory agents, like low-dose aspirin (LDA), might be repurposed in the treatment of early-stage BD. Building on pharmacoepidemiologic and meta-analytic evidence, we conducted the first randomised controlled trial (RCT) testing the effects of add-on LDA in patients with newly diagnosed BD. We hypothesised that add-on treatment with LDA would reduce mood instability (MI), activity instability (AI), and depression severity. METHODS: In this parallel group, triple-blind, superiority RCT, patients newly diagnosed with BD, recruited from a public outpatient mood disorder clinic in the Capital Region of Denmark, were randomised 1:1 to 150 mg acetylsalicylic acid or placebo by an independent third party. The primary outcome was average MI at 6-month follow-up, assessed by the Root Mean Square of Successive Differences (RMSSDs) method. Secondary outcomes included average AI, assessed by the RMSSD method, and change in depressive symptoms, assessed with the 6-item Hamilton Depression Rating Scale, at 6 months. Tertiary outcomes included sleep variability, cognition, manic symptoms and questionnaires at 6 months. RESULTS: Two hundred fifty patients were randomised from January 20, 2022, to May 30, 2024, with the last follow-up on November 18, 2024. Analyses included data from 240 patients (...