Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05329441

Conditions

Depression in Adolescence

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Interventions

Trier Social Stress Test (TSST)

Study Details

Brief 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.

Conditions

Depression in Adolescence

Study ID

NCT05329441

Start date

Jul 6, 2023

Status verified date

May, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Participants

All depressed participants will undergo the same study procedures

Interventions

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.

Primary outcome measure

  • Children's Depressing Rating Scale-Revised [ Time Frame: baseline and 12-week follow-up ]
  • Reynolds Adolescent Depression Scale-2 (RADS-2) [ Time Frame: baseline and 12-week follow-up ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) [ Time Frame: baseline and 12-week follow-up ]

Central Contacts and Locations

Central contacts

Tiffany Ho, Ph.D.

310-825-2961tiffany.ho@psych.ucla.edu

Cheryl Sun, B.A.

cherylsun@psych.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Tiffany Ho, Ph.D.

310-825-0561

Principal Investigator:

Tiffany C Ho, Ph.D.

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • depression
  • adolescence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-29.