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NCT06345859 · ClinicalTrials.gov registry record · Phase 2
Regulation of Affect and Physiology in Depression
A Phase 2 study of Major Depressive Disorder, sponsored by University of Southern California.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 252
- Enrollment target
- 1
- Study location
NCT06345859: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by University of Southern California.
NCT06345859 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 252 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06345859, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 252 participants
- Enrollment target
- 1
- Study location
Study Summary
Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes.
Primary Outcome
A slope representing the strength of the relationship between how much each individual's heart rate variability increases after engaging in adaptive regulation strategies (reappraisal, distraction, and/or acceptance). Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.
Conditions Studied
Interventions
- BEHAVIORAL Heart rate variability biofeedback
Study Locations (1)
California
- University of Southern California - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2024-03-22 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 2 |
What NCT06345859 shows while recruiting
NCT06345859 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Heart rate variability biofeedback is the first listed.
NCT06345859 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06345859 about?
NCT06345859 is a clinical study titled "Regulation of Affect and Physiology in Depression". Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors:...
What is the current status of trial NCT06345859?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2024-03-22. Estimated completion is 2028-05-31.
What conditions does trial NCT06345859 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06345859?
The interventions under investigation include: Heart rate variability biofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT06345859?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06345859 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06345859's enrollment target sits among peer trials
252 59th of 282 higher than 224 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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