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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people ages 14–21 with depression who are seeking treatment. It tests whether short-term stress changes inflammation and glutamate, a brain chemical. It also tests whether these changes predict how well fluoxetine or escitalopram works over 12 weeks and how depression changes over 18 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People of all sexes, genders, and ethnic backgrounds may join.
  • Be 14–21 years old.
  • Be past Tanner stage 3, a measure of puberty.
  • Have taken no medicines that could affect the study for at least 2–6 weeks, depending on the medicine. These include antidepressants, mood stabilizers, hormone supplements, and steroids.
  • Be seeing a clinician who will treat you with fluoxetine or escitalopram.
  • Be able to agree to take part, understand the study, and complete all study steps.
  • Have a caregiver's permission, if needed.

Who can't join

  • Have a main mental health diagnosis other than a depression disorder.
  • Have a health reason that makes MRI scans, blood draws, or SSRI antidepressants unsafe.
  • Use stimulant medicines.
  • Have had a concussion in the past 6 weeks, or any concussion that caused you to pass out for at least 10 minutes.
  • Have an illness that causes inflammation, or use medicines that reduce inflammation, that could affect study results.
  • Have a major brain, nerve, or development disorder that could make it hard to follow study steps.
  • Have ever had mania (very high mood and energy) or psychosis (trouble knowing what is real), or have a diagnosis of bipolar disorder or a substance use disorder.
  • Have a parent, sibling, or child with current, past, or suspected mania or psychosis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * All sexes and genders * All ethnicities * Ages 14-21 * Postpubertal (Tanner stage \> 3) * No medications that will interfere with the study (including antidepressants, mood stabilizers, hormone supplements, steroids, etc.) for at least 2-6 weeks (depending on exact medication) * Currently being seen by a clinician who will treat the participant with fluoxetine or escitalopram * The ability to provide assent, understand, and complete all study procedures * Caregiver consent (if applicable) Exclusion Criteria: * Primary mental health diagnosis other than a depressive disorder according to DSM-V * Any contraindications to MRI scanning, phlebotomy, or SSRI treatment * Stimulant usage * A concussion within the last 6 weeks or any lifetime concussion with loss of consciousness for at least 10 minutes * Any inflammatory conditions or use of anti-inflammatory medications that may influence study findings * Any major neurological or developmental disorders which could impact the participant's ability to comply with study procedure * Meeting for current or lifetime criteria of mania or psychosis, diagnosis of bipolar disorder, or any substance use disorders * First-degree relative with current, past, or suspected mania or psychosis

Study sites (1)

CA