BridgeMD
New treatment option for Major Depressive Disorder
Official title Stress Dynamics and Familial Risk for Depression in Female Adolescents
ClinicalTrials.gov ID: NCT06816329
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 15, women only. Healthy volunteers may be eligible.
You may be able to join if
- General for all Adolescent Cohorts:
- Female sex assigned at birth
- Ages 13-15
- English as first language or English Fluency
- Right-handed
You likely can't join if
- 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
See the full eligibility criteria
- General 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 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
- 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...
- 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...
- 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...
- Any past or current Diagnostic and Statistical Manual (DSM)-5 psychiatric or substance/alcohol use disorder
- First-degree relative history of any psychiatric disorder
The study team makes the final eligibility decision.
Where it's taking place
- Belmont, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 13 years to 15 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belmont, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.