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Recruiting NCT06072677

NCT06072677 Adolescent Mood During Puberty and Testosterone

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Clinical Trial Summary
NCT ID NCT06072677
Status Recruiting
Phase
Sponsor University of North Carolina, Chapel Hill
Condition Adolescent Depression
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2023-08-24
Primary Completion 2027-12

Trial Parameters

Condition Adolescent Depression
Sponsor University of North Carolina, Chapel Hill
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 11 Years
Max Age 14 Years
Start Date 2023-08-24
Completion 2027-12
Interventions
Healthy Minds Program

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Brief 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.

Eligibility 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

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