Stress Dynamics and Familial Risk for Depression in Female Adolescents

NCT06816329 | Recruiting

• 1 other identifier: R01MH137441
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

stress; depression; adolescents; neuroimaging; familial risk

Outcome Measures

Primary Outcomes (3)

• Time Spent in Default Mode-Frontoparietal Network Coactivation Pattern (CAP)

  Time Spent in Default Mode-Frontoparietal Network Coactivation Pattern (CAP). An fMRI variable. (the number of volumes spent in this CAP).

  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 co-activation pattern

  Persistence in default mode network-frontoparietal network CAP. An fMRI measure. (the average number of consecutive volumes spent in this CAP)

  Throughout a 1.75 hour MRI scan collected during the middle of a 3.5 hour 2nd study session

• Depressive Symptoms

  The total score on the Mood and Feelings Questionnaire \[Min Score: 0, Max Score: 66, higher scores mean more severe depressive symptoms)

  Collected at baseline, the beginning of a 1.75 hour MRI, and at 6-, 12-, and 18-month follow-ups

Secondary Outcomes (5)

• Cortisol

  Collected throughout a 3.5 hour second study session that involves a 1.75 hour MRI conducted at the middle of the session

• Stress Ratings

  Collected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectively

• Average heart rate (beats per minute)

  Collected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectively

• heart rate variability

  Collected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectively

• Sleep duration

  Collected during a two-week period immediately after the 2nd study session (i.e., the MRI session), and then in the two-weeks immediately after the 6-, 12-, and 18-month follow-up sessions, respectively

Study Arms (1)

Computer Task Manipulation

EXPERIMENTAL

Participants will complete computer tasks while undergoing an fMRI brain scan.

Behavioral: Computer Task Manipulation

Interventions

Computer Task Manipulation BEHAVIORAL

Participants will complete computer tasks.

Computer Task Manipulation

Eligibility Criteria

• Age: 13 Years - 15 Years
• Gender Eligibility Details: Only female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• A biological parent meeting DSM-5 criteria for at least one past/current major depressive episode

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Emily Belleau, Ph.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Belleau

CONTACT

617-855-4245; ebelleau@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Case-Control Design

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 10, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The research community will have access to data when the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
• Access Criteria: To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable

Locations

US (1)