CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 250 enrolled
Drug / intervention
acetylsalicylic acid +1 moredrug
Likely dose
acetylsalicylic acid 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05035316
NCT05035316Phase 2Completed

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

Lars Vedel Kessing·interventional·Posted Sep 5, 2021·Updated Jan 29, 2025

In Brief

A Phase 2 clinical trial evaluating acetylsalicylic acid and Calcium for Bipolar Disorder. Completed, enrolled 250 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedSep 5, 2021
Enrollment StartJan 20, 2022
Primary CompletionNov 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 4.8 years ago

Interventions

acetylsalicylic aciddrug

Oral tablet: acetylsalicylic acid,150 mg, 1 tablet/day

Calciumdrug

Oral tablet: calcium, 1 tablet/day