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NCT03450135 · ClinicalTrials.gov registry record
Neurophysiology, Estrogen, and Stress Exposure in the Emergence of Depression in Adolescent Girls
A clinical trial of Stress and Adolescent Development, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 53
- Enrollment target
- 1
- Study location
NCT03450135: Completed study of Stress and Adolescent Development, sponsored by University of North Carolina, Chapel Hill.
NCT03450135 is a study of Stress and Adolescent Development that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 53 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03450135, a study of Stress and Adolescent Development, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 53 participants
- Enrollment target
- 1
- Study location
Study 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 (National Institute of Mental Health, 2016). The profound gender disparity in depression that emerges at puberty, but not before, implicates a role of ovarian steroid hormones in promoting affective (mood) symptoms in adolescent girls. In addition to dramatic physical maturation and a rapidly changing reproductive hormone environment at puberty, adolescence is also a time of exposure to substantial psychosocial stress, particularly in girls. It is well documented that stress interferes with the maturation of neurodevelopmental trajectories and is a critical precipitating factor in the pathway to psychopathology. However, the neuropathophysiological mechanisms linking stress exposure and sensitivity to ovarian hormone fluctuations at puberty to the onset and maintenance of depression symptoms in adolescence have yet to be elucidated, and is the purpose of this research.
Primary Outcome
The MFQ consists of 33 descriptive phrases regarding how the subject has been feeling or acting recently (past two weeks) on a 3-point force-choice Likert-type response scales (most of the time, sometimes, or not at all). Greater scores reflect greater symptom severity.
Conditions Studied
Interventions
- BEHAVIORAL Trier Social Stress Test
- BEHAVIORAL Emotional go/no-go task
Study Locations (1)
North Carolina
- University of North Carolina, SHARRP Lab - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2018-02-25 |
| Est. Completion | 2020-06-30 |
What the finished NCT03450135 record still lists
NCT03450135 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions - of which Trier Social Stress Test is the first listed.
NCT03450135 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03450135 about?
NCT03450135 is a clinical study titled "Neurophysiology, Estrogen, and Stress Exposure in the Emergence of Depression in Adolescent Girls". 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 (National Institute of Mental Health, 2016). The profound gender disparity in depression that emerges at p...
What is the current status of trial NCT03450135?
This trial is currently completed. The enrollment target is 53 participants. The study started on 2018-02-25. Estimated completion is 2020-06-30.
What conditions does trial NCT03450135 study?
This clinical trial studies the following conditions: Stress, Adolescent Development, Emotional Disturbances.
What interventions are being tested in trial NCT03450135?
The interventions under investigation include: Trier Social Stress Test (BEHAVIORAL), Emotional go/no-go task (BEHAVIORAL).
Who is sponsoring clinical trial NCT03450135?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03450135 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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53 99th of 152 higher than 50 of 152 other Stress trials
participants (enrollment target), bucketed by value
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