{
  "abstract": "Background/Objectives: Bipolar depression remains difficult to treat. We evaluated the short-term antidepressant efficacy of adjunctive low-dose acetylsalicylic acid (ASA; 150 mg/day) over 2 months and its longer-term effect on relapse prevention over 12 months. Methods: ASPIRIN BD (EudraCT 2021-006635-25) was a multicentre, randomised, double-blind, placebo-controlled phase II trial at four Polish centres. Adults aged 18–60 years with a current bipolar depressive episode were randomised 1:1 to ASA or placebo for 12 months. The primary endpoint was the change in HAMD-17 score after 2 months, while the longer-term effect of ASA on relapse or clinical worsening was assessed over 12 months. Results: One hundred participants were randomised (50 per group). At month 2, ASA reduced HAMD-17 scores versus placebo (adjusted difference −4.24; 95% CI −7.20 to −1.28; p = 0.005; d = −0.51). Relapse or clinical worsening was less frequent with ASA (p = 0.026; NNT = 5). Depressive and bipolar remission rates were higher with ASA at month 6 (both p ≤ 0.003). Safety outcomes and adherence were comparable between groups. Conclusions: Adjunctive ASA 150 mg/day improved short-term depressive symptoms and reduced relapse or clinical worsening during a 12-month treatment period, with no clear safety signal. These findings warrant phase III confirmation.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Pharmacology, Institute of Psychiatry and Neurology, 9 Sobieskiego Street, 02-957 Warsaw, Poland",
    "Department of Psychiatry, Collegium Medicum, Cardinal Stefan Wyszyński University, 01-938 Warsaw, Poland",
    "Department of Pharmacology and Third Department of Psychiatry, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland",
    "Holimedyk Mental Health Institute, 42-200 Częstochowa, Poland",
    "Regional Mental Health Hospital, 86-100 Świecie, Poland"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Monika Dominiak",
      "orcid": "0000-0002-1423-2289"
    },
    {
      "affs": [
        1
      ],
      "name": "Anna Z. Antosik",
      "orcid": "0000-0002-8570-4706"
    },
    {
      "affs": [
        2
      ],
      "name": "Adam Gędek",
      "orcid": "0000-0002-9312-2976"
    },
    {
      "affs": [
        3
      ],
      "name": "Anna Krawczyk-Syguda"
    },
    {
      "affs": [
        4
      ],
      "name": "Sławomir Biedrzycki"
    },
    {
      "affs": [
        0
      ],
      "name": "Julita Kuczyńska"
    },
    {
      "affs": [
        0
      ],
      "name": "Michał Dermanowski",
      "orcid": "0000-0001-8883-8235"
    },
    {
      "affs": [
        0
      ],
      "name": "Paweł Mierzejewski",
      "orcid": "0000-0002-0642-6075"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/87hejts2v9kq3.bib",
  "cited_by": 0,
  "doi": "10.3390/jcm15218349",
  "fulltext_url": null,
  "id": "87hejts2v9kq3",
  "issns": [
    "2077-0383"
  ],
  "landing_url": "https://www.mdpi.com/2077-0383/15/21/8349",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2738|Bipolar Disorder and Treatment"
    ]
  ],
  "openalex": "W7223826212",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-27",
  "publisher": "MDPI AG",
  "ris": "https://research.draconitic.com/paper/87hejts2v9kq3.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:01Z",
      "native_id": "10.3390/jcm15218349",
      "source": "crossref",
      "url": "https://www.mdpi.com/2077-0383/15/21/8349"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2738|Bipolar Disorder and Treatment",
      "subfield": "psychiatry"
    }
  ],
  "title": "Adjunctive Low-Dose Acetylsalicylic Acid in Bipolar Disorder: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Trial (ASPIRIN BD)",
  "title_text": "Adjunctive Low-Dose Acetylsalicylic Acid in Bipolar Disorder: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Trial (ASPIRIN BD)",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:01Z",
  "url": "https://research.draconitic.com/paper/87hejts2v9kq3",
  "venue": "Journal of Clinical Medicine",
  "versions": []
}