Effects of low dose Aspirin in bipolar disorder – a randomized controlled trial

Phase 1

• Conditions: Bipolar disorder; MedDRA version: 21.1Level: LLTClassification code 10004935Term: Bipolar affective disorder, unspecifiedSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-000862-14-DK
• Lead Sponsor: Copenhagen Affective Disorder research Center (CADIC),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

-Bipolar disorder (type 1 or 2), with diagnoses confirmed by SCAN interview.
-Age 18-65 years
-Speaks and writes Danish at a level equal to mother tongue
-Habile (i.e. able to give informed consent)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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:
oReluctance to use effective contraception (IUD or hormonal contraception) during enrollment, including a safety period of one week following last medication day/trial completion
oPregnancy; pregnancy ruled out by HCG test before enrollment
oBreastfeeding
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified