Neurophysiology, Estrogen, and Stress Exposure in the Emergence of Depression in Adolescent Girls

NCT03450135 | Completed

• 2 other identifiers: 17-21732KR961702
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Adolescent Development; Stress; Emotional Disturbances

Keywords

puberty; EEG; estradiol; mood; stress

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 10

Secondary Outcomes (2)

• Theta (4-8 Hz) oscillatory activity elicited during an affective task

  Week 10

• Salivary cortisol response to an acute psychosocial stress manipulation

  Week 10

Study Arms (1)

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.

Behavioral: Trier Social Stress Test; Behavioral: Emotional go/no-go task

Interventions

Trier Social Stress Test BEHAVIORAL

Participants will perform an acute psychosocial stress manipulation (Trier Social Stress Test) involving a speech task and challenging mental arithmetic.

Mid-pubertal girls

Emotional go/no-go task BEHAVIORAL

Participants will perform an emotional go/no-go paradigm to examine electrophysiological (EEG) correlates of cognitive and affective processing.

Mid-pubertal girls

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina, SHARRP Lab

Chapel Hill, North Carolina, 27517, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum samples will be stored to potentially assess neurosteroids and additional stress-responsive biomarkers in the future. Samples will be labelled by subject ID, without personal identifiers.

MeSH Terms

Conditions

Affective Symptoms

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Elizabeth Andersen, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 1, 2018
• Study Start: February 25, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

US (1)