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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
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University College, London

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

Condition or disease
Depression

Detailed 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.


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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
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 controls
Healthy participants with no history of depression



Primary Outcome Measures :
  1. Candidate gene expression [ Time Frame: 6 weeks ]
    Levels of RNA expression for genes associated with cardiovascular risk

  2. Glucocorticoid and mineralocorticoid receptor function [ Time Frame: 6 weeks ]
    Glucocorticoid and mineralocorticoid inhibition of lipopolysaccharide (LPS)-stimulated IL-6 levels.

  3. Regulatory T-cell profiles [ Time Frame: 6 weeks ]
    Measurement of percentages of leukocyte subsets


Biospecimen Retention:   Samples With DNA
Saliva, peripheral blood mononuclear cells, blood serum, blood plasma, RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Depressed patients will be recruited from the PANDA trial. Healthy controls will be recruited from primary care.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
University College, London
British Heart Foundation
Investigators
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Principal Investigator: Glyn Lewis UCL

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02657798     History of Changes
Other Study ID Numbers: 15/0860
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs