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Peer-reviewedCC BY 4.0Journal of Clinical Medicine

Adjunctive Low-Dose Acetylsalicylic Acid in Bipolar Disorder: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Trial (ASPIRIN BD)

  • Monika Dominiak1
  • Anna Z. Antosik2
  • Adam Gędek3
  • Anna Krawczyk-Syguda4
  • Sławomir Biedrzycki5
  • Julita Kuczyńska1
  • Michał Dermanowski1
  • Paweł Mierzejewski1
5 affiliations
  1. 1Department of Pharmacology, Institute of Psychiatry and Neurology, 9 Sobieskiego Street, 02-957 Warsaw, Poland
  2. 2Department of Psychiatry, Collegium Medicum, Cardinal Stefan Wyszyński University, 01-938 Warsaw, Poland
  3. 3Department of Pharmacology and Third Department of Psychiatry, Institute of Psychiatry and Neurology, 02-957 Warsaw, Poland
  4. 4Holimedyk Mental Health Institute, 42-200 Częstochowa, Poland
  5. 5Regional Mental Health Hospital, 86-100 Świecie, Poland
Open at sourceDOICite

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.

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Cite

BibTeXRIS
BibTeX
@article{dominiak2026adjunctive,
  title = {{Adjunctive Low-Dose Acetylsalicylic Acid in Bipolar Disorder: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Trial (ASPIRIN BD)}},
  author = {Monika Dominiak and Anna Z. Antosik and Adam Gędek and Anna Krawczyk-Syguda and Sławomir Biedrzycki and Julita Kuczyńska and Michał Dermanowski and Paweł Mierzejewski},
  journal = {Journal of Clinical Medicine},
  year = {2026},
  month = oct,
  doi = {10.3390/jcm15218349},
  url = {https://www.mdpi.com/2077-0383/15/21/8349},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Adjunctive Low-Dose Acetylsalicylic Acid in Bipolar Disorder: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Trial (ASPIRIN BD)
AU  - Monika Dominiak
AU  - Anna Z. Antosik
AU  - Adam Gędek
AU  - Anna Krawczyk-Syguda
AU  - Sławomir Biedrzycki
AU  - Julita Kuczyńska
AU  - Michał Dermanowski
AU  - Paweł Mierzejewski
PY  - 2026
DA  - 2026/10/27
JO  - Journal of Clinical Medicine
DO  - 10.3390/jcm15218349
UR  - https://www.mdpi.com/2077-0383/15/21/8349
AB  - 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.
SN  - 2077-0383
ER  -