Bipolar DisorderPhase 2NCT05035316
Effects of Low Dose Aspirin in Bipolar Disorder (The A-Bipolar RCT)
A Phase 2 study testing acetylsalicylic acid and Calcium in people with Bipolar Disorder, run by Lars Vedel Kessing at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- acetylsalicylic acid and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jan 2022to 18 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bipolar disorder (type 1 or 2), with diagnoses confirmed by SCAN interview.
- Age 18-65 years
- Habile (i.e. able to give informed consent)
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
BD is increasingly conceived as a multisystem disorder with pathophysiologic abnormalities involving inflammation, oxidative stress imbalance, neurotrophic deficiencies and telomere shortening. Specifically, inflammation has been confirmed to be involved in the pathogenesis of BD. Emerging yet compelling data converge to suggest that aspirin may protect against the onset and deterioration in BD. Nevertheless, a pragmatic large scale RCT is needed to for a conclusive risk-benefit analysis of aspirin and to clarify its therapeutic role at the different clinical stages of BD.The investigators propose to include smartphone-based self-assessment of mood as the primary outcome measure in the RCT. Thus, during the last ten years, the investigators have developed and tested a unique smartphone-based system, the Monsenso system, for monitoring, diagnosing and treating BD.
The trial is designed as a two arm, parallel randomized trial with randomisation 1:1 to add on of low dose aspirin (Hjertemagnyl 150 mg/day) versus add-on of placebo to current treatment and with stratification according to age (< 30 years) and gender. The trial is planned and will be conducted in concordance with the CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. Patients will be included from The Copenhagen Affective Disorder Clinic, which is a mood disorder clinic providing treatment service for patients with newly diagnosed/first episode BD from the entire Capital Region of Denmark covering a catchment area of 1.6 million people and all psychiatric centres in the region. The Clinic receives more than 300 patients with newly diagnosed BD each year.
we wish to test the following hypotheses: Adding LDA versus placebo to standard drug treatment for BD will reduce 1) mood instability (MI), and 2) other critical outcomes such as activity instability and severity of depression.
Finally, we hypothesize that the reduction in MI is higher in patients with systemic inflammation at baseline indexed with the biomarkers high-sensitivity C-reactive protein (hsCRP), IL-6, and soluble urokinase plasminogen activator receptor (suPAR).
- Conditions
- Bipolar Disorder
- Being tested
- acetylsalicylic acid, Calcium
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
Also called Aspirin
Oral tablet: acetylsalicylic acid,150 mg, 1 tablet/day
CalciumDrug
Oral tablet: calcium, 1 tablet/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 125 BD participants will receive placebo. Patients, clinicians and researchers will be blinded for the intervention Receives: Drug: Calcium |
| Active | Active comparator | 125 BD participants will receive active treatment. Patients, clinicians and researchers will be blinded for the intervention Receives: Drug: acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily self-reported mood instability
Daily self-reported mood instability collected via the Monsenso system
Measured: 6 months (12 months for a subgroup of participants)
Secondary outcomes (2)
Depressive symptoms
Depressive symptoms assessed by the Hamilton Depression Rating Scale-6 items (min. value = 0; max. value = 22, with higher values reflecting more depressive symptoms)
Measured: Changes between baseline score and score at 6 months-follow-up
Daily self-reported activity instability
Daily self-reported activity instability collected via the Monsenso App
Measured: Changes between baseline score and score at 6 months-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start20 Jan 2022
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Vedel Kessing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Vedel Kessing, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035316
- Sponsor's protocol ID
- H-21014515
- Other IDs
- 2021-000862-14
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Mar;153(3):214-224. doi: 10.1111/acps.70055. Epub 2025 Nov 30.
PubMed 41319159Bruun 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.
PubMed 39557557
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Dose Aspirin in Bipolar Disorder (The A-Bipolar RCT)
- ClinicalTrials.gov ID
- NCT05035316
- Acronym / sponsor ID
- H-21014515
- Conditions
- Bipolar Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Lars Vedel KessingUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BD is increasingly conceived as a multisystem disorder with pathophysiologic abnormalities involving inflammation, oxidative stress imbalance, neurotrophic deficiencies and telomere shortening. Specifically, inflammation has been confirmed to be involved in the pathogenesis of BD. Emerging yet compelling data converge to suggest that aspirin may protect against the onset and deterioration in BD. Nevertheless, a pragmatic large scale RCT is needed to for a conclusive risk-benefit analysis of aspirin and to clarify its therapeutic role at the different clinical stages of BD.The investigators propose to include smartphone-based self-assessment of mood as the primary outcome measure in the RCT. Thus, during the last ten years, the investigators have developed and tested a unique smartphone-based system, the Monsenso system, for monitoring, diagnosing and treating BD.
The trial is designed as a two arm, parallel randomized trial with randomisation 1:1 to add on of low dose aspirin (Hjertemagnyl 150 mg/day) versus add-on of placebo to current treatment and with stratification according to age (< 30 years) and gender. The trial is planned and will be conducted in concordance with the CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. Patients will be included from The Copenhagen Affective Disorder Clinic, which is a mood disorder clinic providing treatment service for patients with newly diagnosed/first episode BD from the entire Capital Region of Denmark covering a catchment area of 1.6 million people and all psychiatric centres in the region. The Clinic receives more than 300 patients with newly diagnosed BD each year.
we wish to test the following hypotheses: Adding LDA versus placebo to standard drug treatment for BD will reduce 1) mood instability (MI), and 2) other critical outcomes such as activity instability and severity of depression.
Finally, we hypothesize that the reduction in MI is higher in patients with systemic inflammation at baseline indexed with the biomarkers high-sensitivity C-reactive protein (hsCRP), IL-6, and soluble urokinase plasminogen activator receptor (suPAR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Calcium125 BD participants will receive placebo. Patients, clinicians and researchers will be blinded for the intervention |
| Active | Active comparator | Drug: acetylsalicylic acid125 BD participants will receive active treatment. Patients, clinicians and researchers will be blinded for the intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bipolar disorder (type 1 or 2), with diagnoses confirmed by SCAN interview.
- Age 18-65 years
- Habile (i.e. able to give informed consent)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic acidAlso: AspirinOral tablet: acetylsalicylic acid,150 mg, 1 tablet/day | Drug | Active |
| CalciumOral tablet: calcium, 1 tablet/day | Drug | Placebo |
Primary outcome
Daily self-reported mood instability
Time frame: 6 months (12 months for a subgroup of participants)
Daily self-reported mood instability collected via the Monsenso system
2 secondary outcomes
Depressive symptoms
Time frame: Changes between baseline score and score at 6 months-follow-up
Daily self-reported activity instability
Time frame: Changes between baseline score and score at 6 months-follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 41319159Bruun 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. 2026 Mar;153(3):214-224. doi: 10.1111/acps.70055. Epub 2025 Nov 30.
- Derived from this study: PubMed 39557557Bruun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acetylsalicylic acid and Calcium in people with Bipolar Disorder, run by Lars Vedel Kessing at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily self-reported mood instability (time frame: 6 months (12 months for a subgroup of participants)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035316, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.