Adolescent DevelopmentEVOLVENCT03450135
Neurophysiology, Estrogen, and Stress Exposure in the Emergence of Depression in Adolescent Girls
An observational study of Adolescent Development and Stress, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development, Stress, Emotional Disturbances
- What is being tested?
- Trier Social Stress Test and Emotional go/no-go task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, SHARRP Lab
Chapel Hill, North Carolina, 27517
About this study
Official title: Ovarian Hormone Variability and Mood Symptoms in Girls During the Pubertal Transition
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.
Read the 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 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.
- Conditions
- Adolescent Development, Stress, Emotional Disturbances
- Being tested
- Trier Social Stress Test, Emotional go/no-go task
- Keywords
- puberty, EEG, estradiol, mood, stress
- Medical subject headings
- Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestBehavioural
Participants will perform an acute psychosocial stress manipulation (Trier Social Stress Test) involving a speech task and challenging mental arithmetic.
Emotional go/no-go taskBehavioural
Participants will perform an emotional go/no-go paradigm to examine electrophysiological (EEG) correlates of cognitive and affective processing.
| Study group | Role | What they receive |
|---|---|---|
| Mid-pubertal girls | 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. Receives: Behavioral: Trier Social Stress Test; Behavioral: Emotional go/no-go task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 10
Secondary outcomes (2)
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.
Measured: 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).
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start25 Feb 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Elizabeth Andersen, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450135
- Sponsor's protocol ID
- 17-2173
- Other IDs
- 2KR961702
- Acronym
- EVOLVE
- Status last verified
- Nov 2020
- First submitted
- 14 Feb 2018
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Hormone Variability and Mood Symptoms in Girls During the Pubertal Transition
- ClinicalTrials.gov ID
- NCT03450135
- Acronym / sponsor ID
- EVOLVE / 17-2173
- Conditions
- Adolescent Development, Stress, Emotional Disturbances
- Keywords
- puberty, EEG, estradiol, mood, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mid-pubertal girls | – | Behavioral: Trier Social Stress Test, Behavioral: Emotional go/no-go taskAdolescent 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. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trier Social Stress TestParticipants will perform an acute psychosocial stress manipulation (Trier Social Stress Test) involving a speech task and challenging mental arithmetic. | Behavioural | Mid-pubertal girls |
| Emotional go/no-go taskParticipants will perform an emotional go/no-go paradigm to examine electrophysiological (EEG) correlates of cognitive and affective processing. | Behavioural | Mid-pubertal girls |
Primary outcome
Average mood symptom score from Mood and Feelings Questionnaire
Time frame: Week 10
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.
2 secondary outcomes
Theta (4-8 Hz) oscillatory activity elicited during an affective task
Time frame: Week 10
Salivary cortisol response to an acute psychosocial stress manipulation
Time frame: Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Andersen, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Development and Stress, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average mood symptom score from Mood and Feelings Questionnaire (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.