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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source University of California, Los Angeles
Contact Tiffany Ho, Ph.D.
Phone 310-825-2961
Email tiffany.ho@psych.ucla.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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 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

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

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)
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