Inflammatory and Glutamatergic Mechanisms of Sustained Threat in Adolescents With Depression: Toward Predictors of Treatment Response and Clinical Course
New study explores why some teens with depression don't respond to medication.
Plain English Summary
Inflammatory and Glutamatergic Mechanisms of Sustained Threat in Adolescents With Depression is a Not Applicable clinical trial sponsored by University of California, Los Angeles studying Depression in Adolescence. This study tests how stress affects inflammation and brain chemicals in depressed teens. It's for adolescents aged 14-21 diagnosed with depression who are seeking treatment. Participants will undergo a mild stress test, provide blood samples, and have brain scans. Standard antidepressant medications like fluoxetine or escitalopram are the current alternatives. The trial aims to enroll 160 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Teens aged 14-21 with a depression diagnosis can join. Participants must not be taking interfering medications and should be seeing a clinician who will prescribe fluoxetine or escitalopram. Exclusion criteria include other primary mental health diagnoses, conditions preventing MRI or blood draws, recent concussion, inflammatory conditions, or a history of mania or psychosis. This trial is studying Depression in Adolescence, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will measure changes in depression symptoms using standardized scales to see if stress-related biological markers can predict how well teens respond to common antidepressants. The specific primary outcome measures are: Children's Depressing Rating Scale-Revised (baseline and 12-week follow-up); Reynolds Adolescent Depression Scale-2 (RADS-2) (baseline and 12-week follow-up); Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) (baseline and 12-week follow-up). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to identify biological markers that predict which adolescents with depression will respond to standard antidepressant treatment, addressing a significant gap in personalized care. This research targets Depression in Adolescence, where improved treatment options are needed.
Investor Insight
This observational study by UCLA seeks to understand treatment resistance in adolescent depression, potentially leading to more targeted therapies and improving outcomes in a large patient population.
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the stress test involves. Participation includes a mild stress test, blood draws, and brain imaging (MRI). You will be monitored for 18 months to track your progress. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 160 participants
Interventions
- BEHAVIORAL: Trier 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 des
Primary Outcomes
- Children's Depressing Rating Scale-Revised (baseline and 12-week follow-up)
- Reynolds Adolescent Depression Scale-2 (RADS-2) (baseline and 12-week follow-up)
- Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) (baseline and 12-week follow-up)
Secondary Outcomes
- Patient Health Questionnaire-9 (baseline and 12-week follow-up)
- Mood Ratings on the Trier Social Stress Test (Acute (baseline and throughout study procedures))
Full Eligibility Criteria
Inclusion Criteria: * DSM-V criteria for a depressive disorder * 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
Trial Locations
- University of California, Los Angeles, Los Angeles, California, United States
Frequently Asked Questions
What is clinical trial NCT05329441?
NCT05329441 is a Not Applicable OBSERVATIONAL study titled "Inflammatory and Glutamatergic Mechanisms of Sustained Threat in Adolescents With Depression." It is currently recruiting and is sponsored by University of California, Los Angeles. The trial targets enrollment of 160 participants.
What conditions does NCT05329441 study?
This trial investigates treatments for Depression in Adolescence. The primary condition under study is Depression in Adolescence.
What treatments are being tested in NCT05329441?
The interventions being studied include: Trier Social Stress Test (TSST) (BEHAVIORAL). 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 des
What does Not Applicable mean for NCT05329441?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05329441?
This trial is currently "Recruiting." It started on 2023-07-06. The estimated completion date is 2028-04-30.
Who is sponsoring NCT05329441?
NCT05329441 is sponsored by University of California, Los Angeles. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05329441?
The trial aims to enroll 160 participants. The trial is currently recruiting and accepting new participants.
How is NCT05329441 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05329441?
The primary outcome measures are: Children's Depressing Rating Scale-Revised (baseline and 12-week follow-up); Reynolds Adolescent Depression Scale-2 (RADS-2) (baseline and 12-week follow-up); Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) (baseline and 12-week follow-up). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05329441 being conducted?
This trial is being conducted at 1 site, including Los Angeles, California (United States).
Where can I find official information about NCT05329441?
The official record for NCT05329441 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05329441. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05329441 testing in simple terms?
This study tests how stress affects inflammation and brain chemicals in depressed teens. It's for adolescents aged 14-21 diagnosed with depression who are seeking treatment.
Why is this trial significant?
This trial aims to identify biological markers that predict which adolescents with depression will respond to standard antidepressant treatment, addressing a significant gap in personalized care.
What are the potential risks of participating in NCT05329441?
The stress test may cause temporary discomfort or anxiety. Potential side effects from blood draws include bruising or minor pain. MRI scans are generally safe but may cause noise or claustrophobia for some. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05329441?
Ask your doctor if this study is right for you and what the stress test involves. Participation includes a mild stress test, blood draws, and brain imaging (MRI). You will be monitored for 18 months to track your progress. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05329441 signal from an investment perspective?
This observational study by UCLA seeks to understand treatment resistance in adolescent depression, potentially leading to more targeted therapies and improving outcomes in a large patient population. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will undergo a mild stress test, provide blood samples, and have brain scans. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.