McLean Hospital
Belmont, Massachusetts, 02478, United States
Location status: Recruiting
Location contact
Emily Belleau, Ph.D.
CONTACT
Emily Belleau, Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06816329
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.
Interested in participating?
Request Info13 year–15 year
Female
Interventional
Not applicable
Belmont, Massachusetts, 02478, United States
Location status: Recruiting
Emily Belleau, Ph.D.
CONTACT
Emily Belleau, Ph.D.
PRINCIPAL_INVESTIGATOR
Participants in this research study will include female adolescent between the age of 13 to 15, who may or may not have a parental history of depression. About 148 adolescents will take part in this study along with a biological parent/parent(s) over the next five years.
The study will include five sessions over the span of 18-months, including:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
General Inclusion Criteria for all Adolescent Cohorts:
Additional Inclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group:
Exclusion criteria
General Exclusion Criteria for all Adolescent Cohorts:
NicoDerm (nicotine for tobacco dependence) Transderm Scop (scopolamine for motion sickness) Ortho Evra (birth control)
Additional Exclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group:
Additional Exclusion Criteria for Female Adolescents without a Parental History of MDD, low-risk group:
Participants will complete computer tasks.
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).
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)
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)
Time frame: Collected throughout a 3.5 hour second study session that involves a 1.75 hour MRI conducted at the middle of the session
Saliva rating to be collected throughout the fMRI brain scan
Time frame: 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
Stress ratings (0-100 sliding bar scale) collected via smartphone.
Time frame: 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
compute average heart rate through smartwatch technology
Time frame: 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 expressed as the root mean square of successive differences (RMSSD)
Time frame: 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 computed as the difference in minutes between sleep onset and sleep offset
Contact information is provided by the study sponsor or research team.
Mclean Hospital
Other
Tracking the Dynamic Trajectory of Behavioral, Physiological, and Neurobiological Stress Responses in Female Adolescents at High and Low Familial Risk for Depression
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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