An observational study in Adolescent Development, Stress and Emotional Disturbances, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to female participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by University of North Carolina, Chapel Hill · Observational
Among 28 studies in Affective Symptoms with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Affective Symptoms · United States.
Among the 28 studies in Affective Symptoms with a site in United States, this one is one of 4 that started in 2018, is the only observational one, and was the 13th registered.
85 studies on the registry are indexed under Affective Symptoms; 20 are open to participants now.
Browse Affective Symptoms studies →4 of the 28 studies in Affective Symptoms with a site in United States are open now. Recruiting first, the newest first:
Hackensack Meridian Health · Sites in United States
Ages 18+
Cambridge Health Alliance · Sites in United States
Ages 3–18
American Institutes for Research · Sites in United States
Ages 4–10 · Healthy volunteers
Boston University · Sites in United States
Ages 18+ · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Affective Symptoms studies recruiting now, 4 (36%) set no upper age limit and 7 (64%) stop at 75 or younger; 5 take children under 18; 4 take healthy volunteers.
This study: 11 Years to 14 Years · female · healthy volunteers too.
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28 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2018.
This study's enrollment of 53 is below the median of 70 across 21 observational studies indexed under Affective Symptoms.
Median enrollment 50 across the 27 interventional studies, 53 across the 1 observational. Of the 23 that completed or were terminated, 4 (17%) have results posted.
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1 of 28 have an industry lead sponsor. The 10 most frequent:
University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
University of North Carolina, Chapel Hill has 1 study filed under Affective Symptoms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 28 studies in Affective Symptoms with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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 stress exposure in regulating neurophysiological correlates of affective state change in girls (ages 11-14) during the pubertal transition (i.e., Tanner developmental stages 3 or 4). The rationale for examining E2 variability as a diathesis for mood impairment is twofold. First, sensitivity to hormonal flux during specific reproductive events has been shown to trigger affective symptoms in susceptible women, and second, E2 is a powerful neuroregulator of neural networks implicated in depression.
55 peripubertal girls undergoing a healthy pubertal transition will be recruited for the study. Over an 8-week period, depression symptoms (Center for Epidemiological Studies Depression Scale for Children (CES-DC)), anxiety (State Trait Anxiety Inventory (STAI-C)), and perceived stress (perceived stress scale (PSS)), and salivary E2 measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) will be assessed on a weekly basis. An electroencephalogram (EEG) during an emotional go/no-go task will be performed after the 8-week collection period to probe neurophysiological correlates of maturing fronto-limbic circuitry and assess key domains of cognitive and emotional processing impacted by the hormonal milieu. At the follow-up visit, an acute psychosocial stressor (Trier Social Stress Test) will be administered to examine cortisol and autonomic stress reactivity. The central hypothesis of the proposed research is that the amplitude and synchrony of frontal neural oscillations evoked during the cognitive-affective processing paradigm, and cortisol reactivity to the psychosocial stressor will partially mediate the relationship between greater E2 variability and elevated depression symptoms in peripubertal girls, and this relationship will be particularly strong in girls who have experienced recent (within six months) psychosocial stress.
Study will recruit participants of various racial, ethnic and socioeconomic backgrounds, reflective of the local population (60% White, 20% Black or African American, 10% Asian, and 10% Hispanic or Latino). Participants will be recruited from medical offices, schools and community centers (youth groups, church groups) in Orange and Durham Counties.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adolescent girls (ages 11-14) who are undergoing a healthy pubertal transition (Tanner developmental stage 3 or 4) will perform Trier Social Stress Test and Emotional go/no-go task.
Behavioral: Trier Social Stress Test · Behavioral: Emotional go/no-go task
Participants will perform an acute psychosocial stress manipulation (Trier Social Stress Test) involving a speech task and challenging mental arithmetic.
Participants will perform an emotional go/no-go paradigm to examine electrophysiological (EEG) correlates of cognitive and affective processing.
Average mood symptom score from Mood and Feelings Questionnaire
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.
Time frame: Week 10
Theta (4-8 Hz) oscillatory activity elicited during an affective task
Theta oscillations (synchronization of power and phase with respect to stimulus presentation) will be assessed during an emotional go/no-go paradigm to reflect cognitive and emotional processing.
Time frame: Week 10
Salivary cortisol response to an acute psychosocial stress manipulation
The stress hormone cortisol will be assessed at rest and in response to the Trier Social Stress Test at baseline (enrollment).
Time frame: Week 10
Ran from Feb 2018 to primary completion in Jun 2020, 28 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill →