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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06345859
The ClinicalTrials.gov registry entry for NCT06345859 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (33% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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