Effects of Low Dose Aspirin in Bipolar Disorder (The A-Bipolar RCT)
2 other identifiers
interventional
250
1 country
1
Brief Summary
Despite currently available treatment, a large proportion of patients with bipolar disorder (BD) suffer from affective symptoms, impaired psychosocial and cognitive function. Inflammation seems to be involved in the pathogenesis of BD and preliminary data suggest that low-dose Aspirin may have beneficial effects. The objective of this RCT is to investigate whether add on of low dose aspirin versus placebo add on to standard drug treatment improves mood stabilisation and other critical patient outcomes in patients with BD and whether its principal effects are antimanic, antidepressant or prophylactic against relapse. randomized double-blinded placebo-controlled trial will investigate whether augmentation with low dose Aspirin to standard drug treatment improve mood stabilization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2024
CompletedJanuary 29, 2025
January 1, 2024
2.8 years
August 12, 2021
January 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Daily self-reported mood instability
Daily self-reported mood instability collected via the Monsenso system
6 months (12 months for a subgroup of participants)
Secondary Outcomes (2)
Depressive symptoms
Changes between baseline score and score at 6 months-follow-up
Daily self-reported activity instability
Changes between baseline score and score at 6 months-follow-up
Other Outcomes (11)
Automatically smartphone-generated data
6 months
Cognition
Changes between baseline score and score at 6 months-follow-up
Manic symptoms
Changes between baseline levels, 3 and 6 months
- +8 more other outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR125 BD participants will receive placebo. Patients, clinicians and researchers will be blinded for the intervention
Active
ACTIVE COMPARATOR125 BD participants will receive active treatment. Patients, clinicians and researchers will be blinded for the intervention
Interventions
Oral tablet: acetylsalicylic acid,150 mg, 1 tablet/day
Eligibility Criteria
You may qualify if:
- Bipolar disorder (type 1 or 2), with diagnoses confirmed by SCAN interview.
- Age 18-65 years
- Habile (i.e. able to give informed consent)
You may not qualify if:
- Chronic kidney disease with GFR 0-10 ml/min
- Severe cardiac insufficiency (NYHA IIIb-IV)
- History of gastric ulcers, gastro-intestinal bleeding or other pathological bleeding tendency (thrombocytopenia, hemophilia, vitamin K deficiency)
- Asthma or other allergic symptoms developed after intake of salicylates, paracetamol or other NSAID or any of the excipients
- Patients already on aspirin or other NSAID, anticoagulants or SSRIs.
- For fertile females:
- Reluctance to use effective contraception during enrollment, including a safety period of one week following last medication day/trial completion
- Pregnancy; pregnancy ruled out by HCG test before enrollment
- Breastfeeding
- Planned major surgery during trial period. If a subject has scheduled major surgery (i.e. with bleeding risk), enrollment will be postponed until this is completed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatric Center Copenhagen
Copenhagen, 2100, Denmark
Related Publications (2)
Bruun CF, Krogh HB, Zarp J, Stokholm JR, Forman JL, Miskowiak KW, Giraldi A, Vinberg M, Faurholt-Jepsen M, Kessing LV. 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). Acta Psychiatr Scand. 2025 Nov 30. doi: 10.1111/acps.70055. Online ahead of print.
PMID: 41319159DERIVEDBruun CF, Zarp J, Lyng Forman J, Coello K, Miskowiak KW, Vinberg M, Faurholt-Jepsen M, Kessing LV. Effects of low-dose aspirin in bipolar disorder: study protocol for a randomised controlled trial (the A-Bipolar RCT). BMJ Open. 2024 Nov 18;14(11):e084105. doi: 10.1136/bmjopen-2024-084105.
PMID: 39557557DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, researchers and clinicians will be masked for the intervention
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, DMSc.
Study Record Dates
First Submitted
August 12, 2021
First Posted
September 5, 2021
Study Start
January 20, 2022
Primary Completion
November 18, 2024
Study Completion
November 18, 2024
Last Updated
January 29, 2025
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share