Status:
COMPLETED
Neurophysiology, Estrogen, and Stress Exposure in the Emergence of Depression in Adolescent Girls
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Adolescent Development
Stress
Eligibility:
FEMALE
11-14 years
Brief Summary
The prevalence of adolescent depression is steadily rising in the U.S., especially among adolescent girls. Currently 20% of adolescent girls experience major depression compared with 6% of boys (Natio...
Detailed Description
Framed within a diathesis-stress model of disease, the primary objective of this research is to determine a pathophysiological role of estradiol (E2) variability in the context of severe psychosocial ...
Eligibility Criteria
Inclusion
- Female, 11 to 14 years of age
- Meet Tanner developmental stage criteria (as indicated by self-report and pictorial scales of breast and pubic hair development) for pubertal stages 3 or 4
- Must be undergoing a healthy pubertal transition, pre-or-post menarche (within 15 months of menarche, with cycle irregularity)
- Girls must be able to read at a 4th-grade reading level
Exclusion
- Current suicidal intent (based off Columbia-Suicide Severity rating scale)
- A history or current diagnosis of bipolar disorder or psychosis
- Currently on any prescription medications
Key Trial Info
Start Date :
February 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03450135
Start Date
February 25 2018
End Date
June 30 2020
Last Update
November 24 2020
Active Locations (1)
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1
University of North Carolina, SHARRP Lab
Chapel Hill, North Carolina, United States, 27517