RESIST: Understanding the role of depression in heart disease v1.0
Research type
Research Study
Full title
Resist: What are the mechanisms involved in depression and antidepressant resistance that increase cardiovascular risk?
IRAS ID
192778
Contact name
Glyn Lewis
Contact email
Sponsor organisation
Univeristy College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2016/01/12 health research, Data Protection
Duration of Study in the UK
2 years, 6 months, 22 days
Research summary
Cardiovascular disease (CVD) and depression are currently the most common causes of death and disability worldwide. Depression is associated with an increased risk of developing CVD and of CVD-related morbidity and mortality. Depression is common and persistent in patients following heart attack. The biological mechanisms that associate these conditions are poorly understood, however it is widely believed that inflammation may play an important role.
Effective treatment of depression often includes the use of antidepressant medications. Recent studies suggest that the use of antidepressants may improve cardiac outcomes and that patients who do not respond to antidepressant medication may face increased cardiovascular risk. The explanation for this is unclear, however patients who do not respond to antidepressant treatment have also been shown to have higher levels of inflammation.
This study will investigate the effect of anti-depressants on cardiovascular risk in patients with depression, focusing on the role of inflammation. Patients with depression will be recruited from primary care through an existing study (PANDA) where they will be given either sertraline (an anti-depressant) or a placebo. Healthy controls will be recruited from primary care. Participants will be visited either at home or in the GP surgery. They will be given a brief questionnaire regarding their depressive symptoms and saliva and blood will be taken. Six weeks later depressed patients will be re-visited and the tests repeated. Lab analysis will investigate the mechanisms involved, specifically effects on gene expression, corticosteroid receptor function and immune function. Additional analysis will investigate the effects of different types of anti-depressants on immune function in-vitro.
This study, which is funded by the British Heart Foundation, will provide evidence about the role of inflammation in the development of depression and cardiovascular disease. Findings may also identify pathways involved in antidepressant resistance suitable for therapeutic intervention.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0143
Date of REC Opinion
5 Apr 2016
REC opinion
Further Information Favourable Opinion