None listed
Conditions
Brief summary
Depression and atrial fibrillation (AF), an irregular fast rhythm from the top chambers of the heart, are common and often co-existent condition. They show a bidirectional relationship, and the severity of one can affect the severity of the other. Depression also affects the autonomic nervous system, which is a system of nerves that influence internal bodily functions such as heart rate, blood pressure, and digestion, and may influence the development or continuation of AF in this manner. AF can lead to several symptoms, such as palpitations (feeling of heart racing), chest pain, and shortness of breath. It also tends to recur frequently after the first episode. We know from previous studies that treating AF effectively can reduce the incidence of severe depressive symptoms, including suicidal ideation. Some observational data also suggest that treating depression with antidepressants is associated with less AF. We hypothesise that treating depression with a particular common type of antidepressant called an SSRI (selective serotonin reuptake inhibitor) reduces AF-related symptoms. We think that SSRIs will also reduce the time spent in AF (AF burden) and increase the time in between episodes of AF. We think that SSRIs cause these effects by changing the activation of the autonomic nervous system.
Interventions
Oral administration of escitalopram, a selective serotonin reuptake inhibitor (SSRI) antidepressant versus placebo. There are two arms: Arm 1 = escitalopram 10mg once daily with option to titrate up to 20mg once daily, Duration of administration = 12 months.
Materials: baseline, 6-month and 12-month questionnaires as below
1. PHQ-9 questionnaire for depression symptoms https://med.stanford.edu/fastlab/research/imapp/msrs/_jcr_content/main/accordion/accordion_content3/download_256324296/file.res
Oral administration of escitalopram, a selective serotonin reuptake inhibitor (SSRI) antidepressant versus placebo. There are two arms: Arm 1 = escitalopram 10mg once daily with option to titrate up to 20mg once daily, Duration of administration = 12 months. Materials: baseline, 6-month and 12-month questionnaires as below 1. PHQ-9 questionnaire for depression symptoms https://med.stanford.edu/fastlab/research/imapp/msrs/_jcr_content/main/accordion/accordion_content3/download_256324296/file.res/PHQ9%20id%20date%2008.03.pdf 2. AFEQT (AF Effect on Quality of Life) http://www.afeqt.org/files/AFEQT_Questionnaire.pdf 3. SF-36 (Short-form 36 for general quality of life) https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf ECG monitoring: AliveCor phone app (twice daily ECGs) or conventional 3-lead 7-day Holter monitoring Escitalopram dosing may be tailored to an increase from 10mg daily to 20mg daily at the discretion of the reviewing medical practitioner at any of the visits. Provider: medical doctor for prescription and assessment, central clinical trials pharmacy team for medication dispensing, clinical nurse specialist for follow-up visits. Adherence assessment: assessed by pharmacy dispensing records and pill counts by pharmacy personnel.
Sponsors
Melbourne Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Outcome results
None listed