RESIST: Understanding the Role of Depression in Heart Disease
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|ClinicalTrials.gov Identifier: NCT02657798|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Last Update Posted : January 8, 2018
|Condition or disease|
Rationale: Depression is known to be associated with the development of cardiovascular disease and poorer prognosis after cardiac events, however the mechanisms that mediate these links are poorly understood. Inflammatory and neuroendocrine processes are thought to play an important role in this relationship. In addition, antidepressants have been shown to improve cardiac outcomes and have anti-inflammatory effects, whilst inflammation has been shown to be elevated in patients who do not respond to treatment. Several possible biomarkers for antidepressant resistance have also been demonstrated to be cardiovascular risk markers. These include acute phase inflammatory markers, such as interleukin-6 (IL-6), and hypothalamic-pituitary-adrenal axis (HPA) dysregulation.
Design: This will be conducted alongside a larger pharmacological trial, PANDA, where participants will be recruited from primary care and randomized to sertraline (SSRI) or placebo. The RESIST study will compare inflammatory cardiovascular risk factors between depressed patients taking sertraline, depressed patients taking placebo and healthy controls. This will be achieved by investigating the pharmacological effect of antidepressants on gene expression, glucocorticoid and mineralocorticoid receptor function and regulatory T cell (Treg) profiles.
|Study Type :||Observational|
|Actual Enrollment :||90 participants|
|Official Title:||Resist: What Are the Mechanisms Involved in Depression and Antidepressant Resistance That Increase Cardiovascular Risk?|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||September 2018|
Depressed patients taking sertraline
Patients with depression who have been randomised to the sertraline arm in the PANDA trial
Depressed patients taking placebo
Patients with depression who have been randomised to the placebo arm in the PANDA trial
Healthy participants with no history of depression
- Candidate gene expression [ Time Frame: 6 weeks ]Levels of RNA expression for genes associated with cardiovascular risk
- Glucocorticoid and mineralocorticoid receptor function [ Time Frame: 6 weeks ]Glucocorticoid and mineralocorticoid inhibition of lipopolysaccharide (LPS)-stimulated IL-6 levels.
- Regulatory T-cell profiles [ Time Frame: 6 weeks ]Measurement of percentages of leukocyte subsets
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657798
|University College London|
|London, United Kingdom|
|Principal Investigator:||Glyn Lewis||UCL|