No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 27
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
252 (estimated)
Sponsor
University of Southern California · Other
Who this trial is looking for
This trial is looking for young adults aged 18-27 with a history of major depressive disorder who are currently symptom-free, as well as healthy volunteers without a psychiatric history. Participants will take part in assessments of their mood and response to a biofeedback treatment at home over 10 days.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 18-27.
I have been diagnosed with major depressive disorder.
I have been symptom-free for at least eight weeks.
I have a Hamilton Depression Rating Scale score of 7 or less.
I have no lifetime history of any psychiatric disorder.
I have no immediate family members with a mood disorder.
You may not be able to join if
I have changed my psychiatric medication in the last 30 days.
I have autism spectrum disorder.
I currently have an eating disorder.
I have an intellectual disability.
I have a substance use disorder within the past 6 months.
I have any issues that prevent me from having an MRI or ECG.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ho…
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.
Trial Locations
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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 Sca…
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).
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