drugset / Trial / NCT05035316

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

NCT05035316

Phase 2 Completed 250 enrolled Lars Vedel Kessing
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-01-20
Primary completion
2024-11-18
Completion
2024-11-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 150 mg Oral

Indications