Understanding how puberty and testosterone affect adolescent mood
Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program
NA · University of North Carolina, Chapel Hill · NCT06072677
This study is trying to see how puberty and testosterone affect the moods of boys and girls aged 11 to 14 who have had stress or mild depression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 11 Years to 14 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06072677 on ClinicalTrials.gov |
What this trial studies
This research investigates the differences in mood disorders between male and female adolescents during puberty, focusing on how sex hormones may influence these conditions. It aims to identify sex-specific neural and endocrine features that contribute to the increased risk of depression in females and externalizing disorders in males. Participants aged 11 to 14 who have experienced stress or moderate depression will engage with the Healthy Minds Program, utilizing mobile apps to track their mood and responses to hormonal changes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11 to 14 who have experienced a stressful life event or show signs of moderate depression.
Not a fit: Patients with a history of manic episodes, psychotic symptoms, or those currently taking medications that affect neurological function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for adolescent mood disorders.
How similar studies have performed: While there is ongoing research into adolescent mood disorders, this specific focus on sex-specific pathways during puberty is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between the ages of 11 and 14 * Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps * Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher) Exclusion Criteria: * Previous experience with the Healthy Minds Program * Regular meditation practice * Current or history of manic episodes, psychotic symptoms, or current suicidal intent * Taking any form of exogenous hormones or intrauterine device (IUD) within one month of participation in the study * Taking medications that directly alter cardiovascular or neurological function
Where this trial is running
Chapel Hill, North Carolina
- Carolina Crossing B, Suite 1 — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Elizabeth Andersen, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Kayla Jensen, BS
- Email: nerdlab@unc.edu
- Phone: 919-445-6815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adolescent Depression, Puberty, Depression, Mood disturbance, Adolescence, Stress, Peripubertal Transition, Hormones