DepressionNCT02657798
RESIST: Understanding the Role of Depression in Heart Disease
An observational study of Depression, run by University College, London at 1 site in United Kingdom.
Trial summary
This study will investigate the biological pathways involved in anti-depressant resistance that increase risk of cardiovascular disease in people with depression. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Depressed patients will be recruited from the PANDA trial. Healthy controls will be recruited from primary care.
Who may be able to join
- Depressed patients:
- Meet ICD10 criteria from the Clinical Interview Schedule-Revised (CIS-R)
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resist: What Are the Mechanisms Involved in Depression and Antidepressant Resistance That Increase Cardiovascular Risk?
This study will investigate the biological pathways involved in anti-depressant resistance that increase risk of cardiovascular disease in people with depression.
Read the 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.
- Conditions
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candidate gene expression
Levels of RNA expression for genes associated with cardiovascular risk
Measured: 6 weeks
Glucocorticoid and mineralocorticoid receptor function
Glucocorticoid and mineralocorticoid inhibition of lipopolysaccharide (LPS)-stimulated IL-6 levels.
Measured: 6 weeks
Regulatory T-cell profiles
Measurement of percentages of leukocyte subsets
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Glyn Lewis, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657798
- Sponsor's protocol ID
- 15/0860
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2016
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resist: What Are the Mechanisms Involved in Depression and Antidepressant Resistance That Increase Cardiovascular Risk?
- ClinicalTrials.gov ID
- NCT02657798
- Acronym / sponsor ID
- 15/0860
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the biological pathways involved in anti-depressant resistance that increase risk of cardiovascular disease in people with 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Depressed patients will be recruited from the PANDA trial. Healthy controls will be recruited from primary care.
Key inclusion criteria (2 listed)
- Depressed patients:
Key exclusion criteria (11 listed)
- Depressed patients:
- Healthy controls:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glyn Lewis principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candidate gene expression (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.