Sponsor study identifier
Secondary identifiers
NIH
interventional
252
1 country
1
Study Start
March 22, 2024
Actual (reported)Primary Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2024
Actual (reported)March 28, 2024
Actual (reported)April 3, 2024
Actual (reported)April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Physiological regulation success
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.
The two 10-day ambulatory assessment periods.
Average level of heart rate variability
An intercept representing the average level of heart rate variability each person experienced. Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.
The two 10-day ambulatory assessment periods.
Perceived regulation success
The two 10-day ambulatory assessment periods.
Osc+ condition. In the Osc+ condition, participants will see an on-going record of their heart rate over time. They will be instructed to engage in paced breathing and to try to maximize their oscillation score. The paced breathing will be adapted to a rate that allows them to maximize their high amplitude heart rate oscillations.
Osc- condition. In the Osc- condition, participants will also see an on-going record of their heart rate over time, and will be instructed to engage in paced breathing. However, they will be asked to try to keep their heart rate steady and avoid oscillations and will get points on an 'alertness' score that inverts the Osc+ 'oscillation' score.
This is a Phase 2 parallel intervention design with random assignment. We will randomly assign participants to one of two biofeedback conditions. Both conditions involve completing breathing exercises at home, 30 minutes per day for 10 days, while receiving continuous feedback about parasympathetic activity from the computer.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Southern California
Los Angeles, California, 90089, United States
First Submitted
March 28, 2024
First Posted
April 3, 2024
Study Start
March 22, 2024
Actual (reported)Primary Completion
April 30, 2028
Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 4, 2026
Record last verified: 2026-04
Per our data sharing plan, we plan to share the de-identified final research data with the broader scientific community via the National Institute of Mental Health Data Archive. This includes fMRI data, ambulatory data, and clinical, behavioral, and self-report measures.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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