Adolescent Mood During Puberty and Testosterone

Adolescent Depression Clinical Trial

— AMPT  

Official title:

Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072677
• Other study ID #: 23-1336
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Kayla Jensen, BS
• Phone: 919-445-6815
• Email: nerdlab[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Depression
• Depression

Intervention

Behavioral:
• Healthy Minds Program
The Healthy Minds Program is a 4-week mobile program to improve coping and emotion regulation skills. It includes 4 training modules corresponding to key pillars of wellbeing: awareness(focused attention/awareness of thoughts/emotions), connection (empathy, compassion, social connection), insight (clarity of identify/experience) and purpose (applying values/motivations). The Healthy Minds Program includes 2 introductory audio lessons and guided meditations, and each 1-week module includes 2 podcast lessons (5-7 minutes) with psychoeducation and practical examples, and 3 guided meditations relevant to the module topic, for a total of 10 lessons and 14 guided meditations.

Locations

Country	Name	City	State
United States	Carolina Crossing B, Suite 1	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Foundation of Hope, North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CES-DC Score Over Time	The 20-item Center for Epidemiological Studies Depression Scale for Children (CES-DC) will be the primary measure of severity of depressive symptoms. Each item is rated 0 (not at all) to 3 (a lot), with items 4, 8, 12, and 16 being reversed scored. The total CES-DC score may range from 0-60. Higher scores indicate more severe depressive symptoms. Scores of 15 or greater are suggestive of significant depressive symptoms. The overall CES-DC score will be assessed at the end of each week in the study.	up to Week 8