Depression in Adolescence Clinical Trial
— TIGEROfficial title:
Inflammatory and Glutamatergic Mechanisms of Sustained Threat in Adolescents With Depression: Toward Predictors of Treatment Response and Clinical Course
NCT number | NCT05329441 |
Other study ID # | TIGER R01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 6, 2023 |
Est. completion date | April 30, 2028 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | April 30, 2028 |
Est. primary completion date | April 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Columbia University, Mayo Clinic, University of California, Irvine, University of California, San Francisco, University of Southern California |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Generalized Anxiety Disorder-7 | Self-report measure of anxiety severity (dimensional) used for adults (which will facilitate cross-study comparisons) | baseline and 12-week follow-up | |
Other | Multidimensional Anxiety Scale for Children-2 (MASC-2) | Self-report measure of anxiety severity (dimensional) | baseline and 12-week follow-up | |
Other | Glutamate | Change in glutamate (institutional units) in corticolimbic regions following TSST | Acute (baseline and 90 min. follow-up) | |
Other | Glutamate | Change in glutamate (institutional units) in corticolimbic regions after SSRI treatment | baseline and 12-week follow-up | |
Other | IL-6 | Change in peripheral levels of IL-6 (pg/mL) following TSST | Acute (baseline and 90 min. follow-up) | |
Other | IL-6 | Change in peripheral levels of IL-6 (pg/mL) after SSRI treatment | baseline and 12-week follow-up | |
Other | TNF-a | Change in peripheral levels of TNF-a (pg/mL) following TSST | Acute (baseline and 90 min. follow-up) | |
Other | TNF-a | Change in peripheral levels of TNF-a (pg/mL) after SSRI treatment | baseline and 12-week follow-up | |
Other | CRP | Change in peripheral levels of CRP (pg/mL) following TSST | Acute (baseline and 90 min. follow-up) | |
Other | CRP | Change in peripheral levels of CRP (pg/mL) after SSRI treatment | baseline and 12-week follow-up | |
Primary | Children's Depressing Rating Scale-Revised | Clinician-administered assessment of depression severity (dimensional) assessment of depression Clinician-administered assessment of depression severity (dimensional) | baseline and 12-week follow-up | |
Primary | Reynolds Adolescent Depression Scale-2 (RADS-2) | Self-report measure of depression severity (dimensional) | baseline and 12-week follow-up | |
Primary | Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) | The K-SADS-PL is a semi-structured clinical interview designed to yield reliable and valid diagnoses of current and past history of Axis I disorders in children and adolescents. We will use the K-SADS-PL to determine whether a participant is currently depressed, in remission, experiencing relapse or a recurrent episode. From this interview, we will also obtain information such as age of depression onset, number of depressive episodes, medication and therapy usage and changes, etc | baseline and 12-week follow-up | |
Secondary | Patient Health Questionnaire-9 | Self-report measure of depression severity (dimensional) used for adults (which will facilitate cross-study comparisons) | baseline and 12-week follow-up | |
Secondary | Mood Ratings on the Trier Social Stress Test | Visual analogue scale of feeling Afraid, Confused, Sad, Angry, Energetic, Tired, Happy, and Tense from 0 [nothing] to 10 [a bit] | Acute (baseline and throughout study procedures) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05965401 -
Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents
|
N/A | |
Recruiting |
NCT05437588 -
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
|
N/A | |
Recruiting |
NCT04719897 -
Life Experiences in Adolescents and the Development of Skills
|
N/A | |
Active, not recruiting |
NCT05376358 -
Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents
|
N/A | |
Recruiting |
NCT05691439 -
Mechanisms of Depression and Anhedonia in Adolescents: Linking Sleep to Reward- and Stress-Related Brain Function
|
N/A | |
Recruiting |
NCT06139861 -
Better Sleep Study
|
N/A | |
Recruiting |
NCT04747340 -
Clinical Effectiveness of TARA Compared to Standard Treatment for Adolescents and Young Adults With Depression
|
N/A | |
Recruiting |
NCT06273995 -
Telehealth Behavioral Activation for Teens
|
N/A | |
Recruiting |
NCT05712772 -
Neuro-affective Response to Light in Depressed Adolescents and Young Adults
|
N/A | |
Completed |
NCT06213142 -
Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health
|
N/A | |
Completed |
NCT05300204 -
Evaluation of a Website to Improve Depression Literacy in Adolescents With Depression
|
N/A | |
Completed |
NCT05300217 -
Evaluation of a Website to Improve Depression Literacy in Adoldescents
|
N/A | |
Recruiting |
NCT06193772 -
Increasing Treatment Response Rates in Depressed Adolescents Via Feedback-Informed IPDT
|
N/A | |
Completed |
NCT05335564 -
Evaluation of a Website to Improve Depression Literacy in Parents of Adolescents With Depression
|
N/A | |
Completed |
NCT05326178 -
Evaluation of a Website to Improve Depression Literacy in Parents of Healthy Adolescents
|
N/A | |
Completed |
NCT04719949 -
Shaping Actions and Responses to Emotions
|
N/A | |
Not yet recruiting |
NCT05865834 -
Improvement of Mental Health in Adolescents Using E-health Interventions
|
N/A | |
Recruiting |
NCT06387108 -
Evaluation of a Training Course for Educational Professionals
|
N/A | |
Not yet recruiting |
NCT05804877 -
Online MBCT Program for University Students
|
N/A | |
Recruiting |
NCT05617495 -
Mindfulness-Based fMRI Neurofeedback for Depression
|
N/A |