Characterizing Inflammatory Profiles and Suicidal Behavior in Adolescents

NCT04783506 | Completed

• 1 other identifier: STU-2020-1297
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

Despite increasing suicide rates in adolescents, there remains a paucity of approaches to use to prevent re-attempts. Any hope for breaking the code to prevent youth suicide lies in understanding biological factors that play a role. Evidence suggests that inflammation and immune system dysfunction may be linked to suicide. The investigators will develop immune profiles for adolescents with suicidal behavior and those at risk in order to develop tools that can be implemented for prevention efforts. This study involves blood draws, answering questions, and completing questionnaires - no treatment or intervention is provided as part of this study. Participants will be screened to see if they qualify for this study using questionnaires. Participants will be teens (ages 12-18 years) with recent suicidal behavior, teens at-risk for developing depression, and healthy control teens. Participants complete all study-related tasks four times over a period of 12 months. Electronic surveys will be sent to participants to complete monthly. Both the adolescent and if applicable, their parent (or legally authorized representatives, LARs), will answer questions regarding depression, anxiety, and suicidal thoughts/behaviors.

Conditions

Suicide and Depression

Keywords

suicide attempt; suicidal behavior; healthy control; adolescent; observational; depression; suicidal idation; suicide; anxiety; PTSD; substance abuse; healthy teen; depressed teen; children; teenage

Outcome Measures

Primary Outcomes (1)

• Comprehensively characterize inflammatory tone and response

  This will be accomplished by characterization of cells that mediate immune response. Numbers of these cells in blood and how they respond to immune stimulation will be compared between groups of adolescents with varying levels of suicidal behavior.

  Baseline

Secondary Outcomes (1)

• Quantify levels of autoantibodies

  Baseline

Other Outcomes (3)

• Stability of immune signatures

  Baseline, Month 3, Month 6 and Month 12

• Assess immune cell characterization

  Baseline, Month 3, Month 6 and Month 12

• Predict Clinical Health Risk Tracking Scale, Self-report (CHRT-SR) total

  Baseline, Month 3, Month 6 and Month 12

Study Arms (3)

Suicidal Behavior

Adolescents who have suicidal behavior, which for this study, is defined by a recent (within 3 months of enrollment) suicide attempt or suicidal ideation warranting urgent evaluation.

Other: Observational Study

At Risk for Mood Disorders

Adolescents at risk for mood disorders, which for this study, is defined by either personal history of anxiety disorder or substance use disorder or a history of trauma, or a first degree relative with a history of a mood disorder or suicidal history.

Other: Observational Study

Healthy Control

Healthy adolescents with no lifetime history of any psychiatric or substance use disorders or a history of trauma. Additionally, no first-degree family member with a history of a mood disorder or suicidal history.

Other: Observational Study

Interventions

Observational Study OTHER

There is no intervention provided by this study. Observed for 12-month period using questionnaires and study visits.

At Risk for Mood Disorders; Healthy Control; Suicidal Behavior

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with suicidal behavior, at risk for mood disorder, and/or healthy controls will be recruited from several sources. Some examples include existing pathways (i.e., patient population, participants of ongoing/previous longitudinal studies) as well as an open invitation to the public for enrollment.

You may qualify if:

• Study participants must:
• Be adolescents (aged 12-18 years);
• Have the ability to speak, read, and understand English. The parent(s) or legal guardians of minors must also speak, read and understand English;
• Be willing to provide consent/assent. Consent will be provided by parents/LAR/guardian for youth under age 18 or by young adult participant, aged 18. Youth, aged 8-17, must be willing to provide assent;
• Have the ability to complete clinical evaluations and self-report measures;
• Meet criteria for one of these three groups:
• Adolescent with suicidal behaviors, defined as having a recent (within 3 months) suicide attempt or suicidal ideation warranting urgent evaluation;
• Adolescents at risk for mood disorders, defined by either personal history of anxiety disorder or substance use disorder or a history of trauma, or a first degree relative with a history of a mood disorder or suicidal history;
• Healthy adolescents with no lifetime history of any psychiatric or substance use disorders or a history of trauma. Additionally, no first-degree family member with a history of a mood disorder or suicidal history..

You may not qualify if:

• Study participants must not:
• Have current poorly controlled asthma, acute/chronic infection or other medical condition(s) that may affect immune marker levels;
• Have a current medication (e.g., corticosteroids) that may affect immune marker levels of reactivity;
• Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments;
• Be unable to provide a stable home address and contact information

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study will collect biospecimen samples of blood, plasma, serum, PBMCs, DNA. Blood draws will be collected from participants at baseline and at 3 follow-up visits.

MeSH Terms

Conditions

Suicide; Depression; Suicide, Attempted; Anxiety Disorders; Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Madhukar H Trivedi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Founding Director of Center for Depression Research and Clinical Care

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 5, 2021
• Study Start: April 28, 2021
• Primary Completion: June 15, 2025
• Study Completion: August 31, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)