Inflammatory and Glutamatergic Mechanisms of Sustained Threat in Adolescents With Depression
Recruiting · NCT05329441 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, Los Angeles
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of California, Los Angeles - Los Angeles, California, United States