RESIST: Understanding the Role of Depression in Heart Disease

Depression Clinical Trial

Official title:

Resist: What Are the Mechanisms Involved in Depression and Antidepressant Resistance That Increase Cardiovascular Risk?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657798
• Other study ID #: 15/0860
• Status: Completed
• Start date: June 2016
• Est. completion date: November 2018

Study information

• Verified date: March 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will investigate the biological pathways involved in anti-depressant resistance that increase risk of cardiovascular disease in people with depression.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Depressed patients:

• Meet ICD10 criteria from the Clinical Interview Schedule-Revised (CIS-R)

Exclusion Criteria:

• Depressed patients:

• Are taking any anti-inflammatory drugs or drugs which interfere with HPA-axis function, endothelial function, circadian rhythm or any other pathways under investigation

• Unable to read, understand and/or complete questionnaires

• Other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, and eating disorder

• Vulnerable adults

• Healthy controls:

• Have a history of depression

• Are taking any anti-inflammatory drugs or drugs which interfere with HPA-axis function, endothelial function or circadian rhythm or any other pathways under investigation

• Unable to read, understand and/or complete questionnaires

• Other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, and eating disorder

• Vulnerable adults

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Candidate gene expression	Levels of RNA expression for genes associated with cardiovascular risk	6 weeks
Primary	Glucocorticoid and mineralocorticoid receptor function	Glucocorticoid and mineralocorticoid inhibition of lipopolysaccharide (LPS)-stimulated IL-6 levels.	6 weeks
Primary	Regulatory T-cell profiles	Measurement of percentages of leukocyte subsets	6 weeks