NCT06816329Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. okt. 23. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 148 (tervezett)
- Első benyújtás
- 2025. jan. 28.
- Kezdés
- 2025. okt. 15.
- Elsődleges befejezés
- 2030. márc. 31.
- Fő szponzor
- Mclean Hospital
- Betegségek
- Depresszió
- NCT-szám
- NCT06816329
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 148
- 2025. okt. 15. és az elsődleges befejezés (2030. márc. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- 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
Laborértékek
- Clinical/Laboratory Evidence of Hypothyroidism or Hyperthyroidism
Egyéb
- 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)
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 13 év – 15 év · Nem: csak nők · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| McLean Hospital | Belmont | Egyesült Államok | Toboroz |
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