NCT06816329Recruiting
Stress Dynamics and Familial Risk for Depression in Female Adolescents
Tracking the Dynamic Trajectory of Behavioral, Physiological, and Neurobiological Stress Responses in Female Adolescents at High and Low Familial Risk for Depression
Source: ClinicalTrials.gov · Last updated 23 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Mclean Hospital
- Diseases
- Depression
- NCT number
- NCT06816329
What you commit to
- Study type: Interventional
- Planned participants: 148
- From 15 Oct 2025 to the primary completion date, 31 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Implanted drug pumps
- Ear or eye implants
- Other metallic surgical hardware in vital area
- Use of hormonal replacement therapy, anabolic steroids
- Lifetime use of any psychotropic medication
Other illness
- Cardiac pacemakers
- Artificial heart valve, artificial arms, hands, legs, etc.
- Presence of medical or neurological illness that could impact fMRI measures of cerebral blood flow (e.g., head injury resulting in loss of consciousness greater than 5 minutes, seizure, tic disorder, serious/unstable cardiac, hepatic, renal, respiratory, endocrine, neurologic or hematologic illnesses)
- Lifetime history of electroconvulsive therapy
- Diagnosis of a neurodevelopmental disorder (e.g., Autism Spectrum Disorder, Learning Disorder w/ impairment in reading) that would interfere with study tasks (e.g., understanding and completing lengthy battery of questionnaires, ability to complete fMRI scan session and tasks without moving)
- Additional Exclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group:
- Lifetime or current Diagnostic and Statistical Manual (DSM)-5 diagnoses of MDD, persistent depressive disorder, schizophrenia spectrum or other psychotic disorder, bipolar disorder, substance/alcohol use disorder, eating disorders, and posttraumatic stress disorder
- Additional Exclusion Criteria for Female Adolescents without a Parental History of MDD, low-risk group:
- Any past or current Diagnostic and Statistical Manual (DSM)-5 psychiatric or substance/alcohol use disorder
- First-degree relative history of any psychiatric disorder
Lab values
- Clinical/Laboratory Evidence of Hypothyroidism or Hyperthyroidism
Other
- Presence of any contraindication for MRI:
- Metal clips on blood vessels (also called stents)
- Brain stimulator devices
- Known metal fragments in eyes
- Exposure to metal filings or shrapnel (sheet metal workers, welders, and others)
- 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)
- Current tobacco product use
- Clinically significant levels of depressive symptoms according to the Children's Depression Rating Scale-Revised (T Score \> 54, Poznanski et al., 1996)
Who the study is looking for
- 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
Age in the registry: 13 years to 15 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.