Effects of Low Dose Aspirin in Bipolar Disorder (The A-Bipolar RCT)

H-21014515

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.

2022-01-20

2024-12-01

2024-12-01

Recruiting

Early phase I

250

Inclusion Criteria: * Bipolar disorder (type 1 or 2), with diagnoses confirmed by SCAN interview. * Age 18-65 years * Habile (i.e. able to give informed consent) Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded randomized placebo-controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Participants, researchers and clinicians will be masked for the intervention', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

2024-01-17