NCT05035316CompletedPhase 2
Effects of Low Dose Aspirin in Bipolar Disorder (The A-Bipolar RCT)
Source: ClinicalTrials.gov · Last updated 29 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (actual)
- First submitted
- 12 Aug 2021
- Start date
- 20 Jan 2022
- Primary completion date
- 18 Nov 2024
- Lead sponsor
- Lars Vedel Kessing
- Diseases
- Bipolar disorder
- NCT number
- NCT05035316
- EudraCT number
- 2021-000862-14
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 250
- From 20 Jan 2022 to the primary completion date, 18 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- 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
Lab values
- Chronic kidney disease with GFR 0-10 ml/min
Other
- Patients already on aspirin or other NSAID, anticoagulants or SSRIs.
Who the study is looking for
- Bipolar disorder (type 1 or 2), with diagnoses confirmed by SCAN interview.
- Age 18-65 years
- Habile (i.e. able to give informed consent)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psychiatric Center Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.