NCT06345859 Regulation of Affect and Physiology in Depression
| NCT ID | NCT06345859 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Southern California |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2024-03-22 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 252 participants in total. It began in 2024-03-22 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria for Participants with Remitted Depression: 1. Age 18-27. 2. Meeting criteria for lifetime major depressive disorder. 3. Currently meeting criteria for full remission (absence of clinically significant symptoms) for at least eight weeks, and having a Hamilton Depression Rating Scale score of less than or equal to 7. Inclusion Criteria for Healthy Volunteer Participants: 1. Age 18-27. 2. No lifetime history of any psychiatric disorder. 3. No first-degree relatives with a mood disorder. Exclusion Criteria (same for all participants): 1. Change in psychotropic medication use within the last 30 days 2. Autism spectrum disorder 3. Current eating disorder 4. Intellectual disability 5. Substance use disorder within the past 6 months 6. Contraindications for magnetic resonance imaging or electrocardiogram assessment (e.g., presence of metal in body, claustrophobia, cardiac device, pregnancy).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06345859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 27 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06345859 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06345859 currently recruiting?
Yes, NCT06345859 is actively recruiting participants. Contact the research team at carlab@usc.edu for enrollment information.
Where is the NCT06345859 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06345859 clinical trial?
NCT06345859 is sponsored by University of Southern California. The trial plans to enroll 252 participants.