Examining how daily stress affects blood vessel function in adults with depression
Linking Affective Dynamics in Response to Daily Stress to Peripheral Vascular Function in Working Age Adults
This study is trying to see how daily stress affects blood vessel health in adults with depression compared to those without it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT06860724 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the relationship between negative emotional responses to daily stressors and blood vessel function in working-age adults, particularly focusing on those with major depressive disorder (MDD). It will assess how heightened negative affective responsivity (NA-R) to everyday stress impacts nitric oxide-mediated dilation of blood vessels. Participants will include both healthy adults and those diagnosed with MDD, and their emotional and physiological responses will be monitored over a 14-day period. The study seeks to uncover the physiological mechanisms linking emotional dysregulation and cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates are working-age adults aged 18-55, including both those with major depressive disorder and non-depressed healthy individuals.
Not a fit: Patients with unstable or chronic clinical diseases, including severe cardiovascular or metabolic conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment of cardiovascular risks associated with depression.
How similar studies have performed: Other studies have indicated a link between emotional responses to stress and cardiovascular health, suggesting this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females aged 18-55 yrs * Non-depressed health adults (HA) will have no evidence of current or lifetime history of major psychiatric illness, assessed by the MINI and self-report and confirmed by a Licensed Clinical Psychologist * Adults with major depressive disorder (MDD) must meet the DSM-5 criteria for MDD and be currently symptomatic, assessed by the MINI and confirmed by a Licensed Clinical Psychologist; participants with co-morbid anxiety, stress, and trauma-related disorders will be included * Absence of unstable or chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease, as determined by medical history, physical examination, blood chemistries, and 12-lead resting electrocardiogram; however, to ensure a more generalizable sample, adults with elevated systolic BP (\<130mmHg), direct low-density lipoprotein (\<160mg/dl), and glucose (HbA1c \<5.7%) will be included * Participants must have a level of understanding of the English language sufficient to provide informed consent and to agree to all tests and procedures, as well as the capacity and willingness to attend all study related visits and to comply with the study protocol Exclusion Criteria: Subjects will be excluded at the discretion of the PI/collaborating clinicians or for any of the following reasons: * \<18 or \>55 yrs * Lifetime or current co-morbid neuropsychiatric disease (bipolar disorder, psychotic disorders, schizophrenia, eating disorders, obsessive-compulsive disorder, alcohol or substance use disorders) * Serious and imminent active suicidal/homicidal ideation with intent, plans, or behaviors, determined by the Licensed Clinical Psychologist or other clinical study team staff * Diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease, as determined by medical history, physical examination (resting systolic BP ≥130mmHg, body mass index ≥35 kg/m2), clinically significant abnormal blood chemistries (direct low-density lipoprotein ≥160mg/dl, HbA1c≥5.7%), and clinically significant abnormal 12-lead resting ECG * Current or recent use (within last 8 wks) of medications that alter cardiovascular function or psychoactive or psychopharmacological drugs \[including (but not limited to) antidepressants, antipsychotics, benzodiazepines, mood stabilizers, sedatives/hypnotics, dopaminergic agents, stimulants, buspirone, and triptans\] * Tobacco use (including electronic cigarettes) * Females who are pregnant, breastfeeding, or planning to become pregnant; female subjects of child-bearing age must have a negative urine pregnancy test on the day of all experimental visits * Current or past use of hormone replacement therapy * Allergy to study drugs or pharmacological agents
Where this trial is running
Newark, Delaware
- University of Delaware — Newark, Delaware, United States (Recruiting)
Study contacts
- Study coordinator: Jody Greaney, PhD
- Email: jgreaney@udel.edu
- Phone: 302-831-2193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.