NCT06816329 · Mclean Hospital
Stress Dynamics and Familial Risk for Depression in Female Adolescents
What this study is about
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. .
View original scientific description
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.
Interventions
BEHAVIORAL
Computer Task Manipulation
Participants will complete computer tasks.
Primary outcome measures
Time Spent in Default Mode-Frontoparietal Network Coactivation Pattern (CAP)
Time frame: Throughout a 1.75 hour MRI scan collected during the middle of a 3.5 hour 2nd study session
Time Spent in Default Mode-Frontoparietal Network Coactivation Pattern (CAP). An fMRI variable. (the number of volumes spent in this CAP).
Persistence in default mode network-frontoparietal network co-activation pattern
Time frame: Throughout a 1.75 hour MRI scan collected during the middle of a 3.5 hour 2nd study session
Persistence in default mode network-frontoparietal network CAP. An fMRI measure. (the average number of consecutive volumes spent in this CAP)
Depressive Symptoms
Time frame: Collected at baseline, the beginning of a 1.75 hour MRI, and at 6-, 12-, and 18-month follow-ups
The total score on the Mood and Feelings Questionnaire \[Min Score: 0, Max Score: 66, higher scores mean more severe depressive symptoms)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- General Inclusion Criteria for all Adolescent Cohorts:
- Female sex assigned at birth
- 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 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)
- Clinical/Laboratory Evidence of Hypothyroidism or Hyperthyroidism
- Use of hormonal replacement therapy, anabolic steroids
- Lifetime history of electroconvulsive therapy
- Current tobacco product use
- Lifetime use of any psychotropic medication
- Clinically significant levels of depressive symptoms according to the Children's Depression Rating Scale-Revised (T Score \> 54, Poznanski et al., 1996)
- 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
Where
- Belmont, Massachusetts
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 23, 2025 · Source of record for eligibility and locations