Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT)
Introduction 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 c...
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BMJ Publishing Group
2024-11-01
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| author | Maria Faurholt-Jepsen Maj Vinberg Lars Vedel Kessing Julie Lyng Forman Kamilla Woznica Miskowiak Klara Coello Caroline Fussing Bruun Jeff Zarp |
| author_facet | Maria Faurholt-Jepsen Maj Vinberg Lars Vedel Kessing Julie Lyng Forman Kamilla Woznica Miskowiak Klara Coello Caroline Fussing Bruun Jeff Zarp |
| author_sort | Maria Faurholt-Jepsen |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05035316. |
| format | Article |
| id | doaj-art-2ec73ae8d49e416a8d94cf76baea3367 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-2ec73ae8d49e416a8d94cf76baea33672024-11-22T05:30:09ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2024-084105Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT)Maria Faurholt-Jepsen0Maj Vinberg1Lars Vedel Kessing2Julie Lyng Forman3Kamilla Woznica Miskowiak4Klara Coello5Caroline Fussing Bruun6Jeff Zarp7Psychiatric Centre Copenhagen, Copenhagen Affective Disorder Research Centre (CADIC), Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, DenmarkFaculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkPsychiatric Centre Copenhagen, Copenhagen Affective Disorder Research Centre (CADIC), Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, DenmarkSection of Biostatistics, Department of Public Health, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, DenmarkPsychiatric Centre Copenhagen, Copenhagen Affective Disorder Research Centre (CADIC), Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, DenmarkPsychiatric Centre Copenhagen, Copenhagen Affective Disorder Research Centre (CADIC), Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, DenmarkPsychiatric Centre Copenhagen, Copenhagen Affective Disorder Research Centre (CADIC), Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, DenmarkPsychiatric Centre Copenhagen, Copenhagen Affective Disorder Research Centre (CADIC), Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, DenmarkIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05035316.https://bmjopen.bmj.com/content/14/11/e084105.full |
| spellingShingle | Maria Faurholt-Jepsen Maj Vinberg Lars Vedel Kessing Julie Lyng Forman Kamilla Woznica Miskowiak Klara Coello Caroline Fussing Bruun Jeff Zarp Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT) BMJ Open |
| title | Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT) |
| title_full | Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT) |
| title_fullStr | Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT) |
| title_full_unstemmed | Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT) |
| title_short | Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT) |
| title_sort | effects of low dose aspirin in bipolar disorder study protocol for a randomised controlled trial the a bipolar rct |
| url | https://bmjopen.bmj.com/content/14/11/e084105.full |
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