The SAD-AF trial: a study of escitalopram (a selective serotonin reuptake inhibitor, SSRI) antidepressant vs placebo in patients with atrial fibrillation (AF) and depression, on AF-related quality of life

Phase 3

• Conditions: atrial fibrillation; major depressive disorder; Cardiovascular - Other cardiovascular diseases; Mental Health - Depression

• Registration Number: ACTRN12623000227695
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-03
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

•Age greater than or equals to 18 years old
•Paroxysmal AF (atrial fibrillation and/or flutter), with minimum 2 episodes in the last 6 months or persistent AF requiring direct cardioversion
•Score of >=5/27 on the PHQ-9.

Exclusion Criteria

•Presence of significant psychiatric comorbidity where it is considered unsafe to alter current treatment regimen
•Presence of significant cognitive impairment
•Inability or unwillingness to provide informed consent
•Permanent AF (where sinus rhythm cannot be restored)
•Advanced heart failure, as defined by left ventricular ejection fraction < 35%.
•Severe renal impairment defined as creatinine clearance <=30ml/min
•Hepatic impairment defined as the presence of cirrhosis
•Life expectancy <= 24 months due to co-morbid non-cardiac illness, including liver failure, end-stage renal disease or advanced malignancy.
•Age > 85 years-old
•Critically unwell patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in AF Effect on Quality of Life (AFEQT) score[AF related quality of life, measured by patient-completed AFEQT (AF effect on quality of life) questionnaire. This is measured at baseline, 3 months, 6 months and 12 months (primary timepoint) after intervention commencement.]