Stress Dynamics and Familial Risk for Depression in Female Adolescents
Recruiting · NCT06816329 · Interventional (participants receive a specific treatment) · Lead sponsor: Mclean Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. . 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 take part
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 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 it is running
1 location listed across 1 US state.
- McLean Hospital - Belmont, Massachusetts, United States