Stress Dynamics and Familial Risk for Depression in Female Adolescents (NCT06816329) | Clinical Trial Compass
RecruitingNot Applicable
Stress Dynamics and Familial Risk for Depression in Female Adolescents
United States148 participantsStarted 2025-10-15
Plain-language summary
Stress and a parental history of major depressive disorder (MDD) are among the strongest risk factors for future development of MDD. Studies have shown that having a parental history of MDD may be associated with behavioral, psychophysiological, and hormonal responses to stress that are associated with poorer stress coping. . Adolescence is a vulnerable developmental window linked to increased MDD risk, especially for females, as rates of MDD surge relative to males. Despite the central role of stress in MDD onset, little is known about the brain mechanisms underlying stress responses in susceptible female adolescents at high familial risk for MDD. Also, it is unclear how stress-related brain network alterations may relate to "real-world" maladaptive stress responses and whether these stress-related brain network changes are predictive of future depression onset. We will fulfill these research gaps by combining neuroimaging with intensive longitudinal tracking of depressive symptomology as well as behavioral and physiological responses to "real world" stress using smartphone and smartwatch technology. Elucidating these neural mechanisms may aid in the discovery of MDD biomarkers that could identify youth at greatest risk for future MDD development and lead to earlier intervention efforts.
Who can participate
Age range
13 Years – 15 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: General Inclusion Criteria for all Adolescent Cohorts:
* Female sex assigned at birth
* Ages 13-15
* English as first language or English Fluency
* Right-handed
* Have a personal cell phone to complete the ecological momentary assessments
* Ability to give signed, informed consent/assent either written or electronic (via RedCap eConsent)
* Normal or corrected to normal vision and hearing
Additional Inclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group:
• A biological parent meeting DSM-5 criteria for at least one past/current major depressive episode
Exclusion Criteria: General Exclusion Criteria for all Adolescent Cohorts:
• Presence of any contraindication for MRI:
* Cardiac pacemakers
* Metal clips on blood vessels (also called stents)
* Artificial heart valve, artificial arms, hands, legs, etc.
* Brain stimulator devices
* Implanted drug pumps
* Ear or eye implants
* Known metal fragments in eyes
* Exposure to metal filings or shrapnel (sheet metal workers, welders, and others)
* Other metallic surgical hardware in vital area
* Certain tattoos with metallic ink
* Certain intrauterine devices (IUDs) containing metal
* Any other metallic objects that are deemed a contraindication to MRI that cannot be removed
* Certain transdermal (skin) patches such as:
NicoDerm (nicotine for tobacco dependence) Transderm Scop (scopolamine for motion sickness) Ortho Evra (birth control)
* Presence of medical or neurological il…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time Spent in Default Mode-Frontoparietal Network Coactivation Pattern (CAP)
Timeframe: Throughout a 1.75 hour MRI scan collected during the middle of a 3.5 hour 2nd study session
2
Persistence in default mode network-frontoparietal network co-activation pattern
Timeframe: Throughout a 1.75 hour MRI scan collected during the middle of a 3.5 hour 2nd study session
3
Depressive Symptoms
Timeframe: Collected at baseline, the beginning of a 1.75 hour MRI, and at 6-, 12-, and 18-month follow-ups