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NCT04838262 · ClinicalTrials.gov registry record · NA
Stress and the Sympathetic Nervous System in Adults With Depression
A NA study, sponsored by University of Delaware.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
NCT04838262 is a NA study that has completed, run by University of Delaware. The registered enrollment target is 94 participants.
The verdict
NCT04838262, a NA study, has completed, sponsored by University of Delaware.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
Study Summary
To test our hypotheses, we will enroll healthy adults having no history of mood disorders and adults with major depressive disorder (MDD) having a broad range of depressive symptom severity. After screening, subjects will meet with the research coordinator or an investigator for a discussion, with opportunity for questions, before applicable consent forms are obtained. Daily stress processes will be assessed using an ecological momentary assessment approach for 8 consecutive days. On the last day of the daily stress assessment, we will directly measure muscle sympathetic nerve activity, blood pressure, and heart rate during acute laboratory-based cognitive, emotional, and physiological interventions to induce a stress response. A venous blood sample will be taken for measurements of metabolic and renal health and systemic inflammation. Aim 1: To examine the effect of daily psychosocial stressor exposure on acute sympathetic stress reactivity in MDD. Two stressor exposure indicators will be calculated: stressor frequency (i.e., percentage of interview days during which at least one stressor occurred) and total stress (i.e., total number of stressors reported across all interview days) and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults. Aim 2: To determine the relation between negative affective reactivity to daily psychosocial stressor exposure and acute sympathetic stress reactivity in MDD. Negative affective reactivity will be calculated as the change in affect on days when stressors occurred compared to one's typical affect on non-stressor days and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults.
Interventions
- OTHER Acute Stressors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2023-04-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04838262
The ClinicalTrials.gov registry entry for NCT04838262 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Delaware, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acute Stressors is the first listed.
NCT04838262 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04838262 about?
NCT04838262 is a clinical study titled "Stress and the Sympathetic Nervous System in Adults With Depression". To test our hypotheses, we will enroll healthy adults having no history of mood disorders and adults with major depressive disorder (MDD) having a broad range of depressive symptom severity. After screening, subjects will meet with the research coordinator or an investigator for a discussion, with o...
What is the current status of trial NCT04838262?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2021-05-01. Estimated completion is 2023-04-27.
What interventions are being tested in trial NCT04838262?
The interventions under investigation include: Acute Stressors (OTHER).
Who is sponsoring clinical trial NCT04838262?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
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