RecruitingNCT05329441

Inflammatory and Glutamatergic Mechanisms of Sustained Threat in Adolescents With Depression

Inflammatory and Glutamatergic Mechanisms of Sustained Threat in Adolescents With Depression: Toward Predictors of Treatment Response and Clinical Course


Sponsor

University of California, Los Angeles

Enrollment

160 participants

Start Date

Jul 6, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Despite the prevalence and significant public health concern over depression among adolescents, up to 40% of depressed adolescents do not respond to first-line antidepressants (herein termed treatment non-response, TNR). The goal of this project is to recruit and assess 160 treatment-seeking depressed adolescents and test whether acute stress impacts peripheral levels of inflammation and downstream levels of glutamate in corticolimbic regions previously associated with depression, whether these stress-related biomarkers predict TNR to a 12-week trial of either fluoxetine or escitalopram, and whether these stress-related biomarkers predict 18-month clinical course.


Eligibility

Min Age: 14 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether inflammation and brain chemistry changes (specifically involving the neurotransmitter glutamate) explain why some depressed teenagers feel under constant threat and lose motivation, and whether antidepressants improve these brain changes. **You may be eligible if...** - You are 14–21 years old - You meet the criteria for a depressive disorder - You have gone through puberty - You are not currently on medications that interfere with the study (must be off antidepressants for 2–6 weeks) - Your clinician plans to treat you with fluoxetine (Prozac) or escitalopram (Lexapro) **You may NOT be eligible if...** - Your primary diagnosis is something other than depression - You are on stimulant medications - You have had a concussion in the last 6 weeks with loss of consciousness - You have a history of mania, psychosis, or bipolar disorder - You have inflammatory conditions or take anti-inflammatory medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTrier Social Stress Test (TSST)

In this mechanistic study, all participants will undergo a modified version of the Trier Social Stress Test (TSST), which is a well-validated psychosocial stress paradigm, adapted for adolescents that involves no deception and is considered a very mild stressor. The TSST comprises of two stress tests: a 5-minute arithmetic task and a 5-minute speech task. Due to repeated testing of the TSST, participants will be randomized to one task at T1 and complete the second task at T2 (counterbalanced design). Every 5 minutes, participants will provide ratings of their mood using a visual analogue scale (1-10) of eight mood states (Afraid, Confused, Sad, Angry, Energetic, Tired, Happy, and Tense) that will be used as potential behavioral responses to social stress. Glutamate and inflammation outcomes will be examined acutely and from T1 and T2.


Locations(1)

University of California, Los Angeles

Los Angeles, California, United States

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NCT05329441


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