Suicide and DepressionNCT04783506
Characterizing Inflammatory Profiles and Suicidal Behavior in Adolescents
An observational study of Suicide and Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide and Depression
- What is being tested?
- Observational Study
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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:
Show all 9Show fewer
- 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..
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
About this study
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.
Read the detailed description
The purpose of this study is to map inflammatory dysfunction to suicidal behavior and establish a reliable immune signature of suicide risk that can 1) guide future research into fundamental pathophysiology and 2) identify targets for drug development and guide clinical screening and risk management.
Background: In previous research, the investigators have identified targets of clinical utility for both suicide-risk identification and novel therapeutic development. Specifically, a state of immune hyper-reactivity that predisposes to suicidal behavior can be corrected by use of immunomodulatory agents.
Blood tests screening for presence of autoantibodies may be implemented as diagnostic tests to predict future suicide risk. Monoclonal antibodies have gained recent attention for their use in CNS disorders (such as multiple sclerosis and migraine) and have been shown to be effective for some patients with depression.
However, the utility of anti-inflammatory treatments for depression has been limited by a lack of biomarkers to guide their use. Thus, presence of autoantibodies may identify a sub-group of adolescents and young adults with suicidality who are candidates for treatment with monoclonal antibodies.
The investigators specifically hypothesize that depressed youths with suicide behavior have immune hyper-reactivity, as reflected in dysfunctional cells mediating both innate and adaptive immune response.
Study Items: Since this is an observational study, investigators will explore a comprehensive panel of carefully selected participant specific parameters: socio-demographic (age, ethnicity, economic); symptom severity measures (depressive symptoms, mood, and feelings); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood), behavioral (cognitive, emotional), with the goal to develop the most robust predictive models of treatment response and of depression outcomes. There is no medication or non-medication treatment or intervention provided by this study.
- Conditions
- Suicide and Depression
- Being tested
- Observational Study
- Keywords
- suicide attempt, suicidal behavior, healthy control, adolescent, observational, depression, suicidal idation, suicide, anxiety, PTSD, substance abuse, healthy teen, depressed teen, children, teenage
- Medical subject headings
- Suicide, Depression, Suicide, Attempted, Anxiety Disorders, Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
There is no intervention provided by this study. Observed for 12-month period using questionnaires and study visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Quantify levels of autoantibodies
This will be accomplished by measurement of antibodies against a broad panel of autoantigen. Levels of these autoantibodies will be compared between groups of adolescents with varying levels of suicidal behavior.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start28 Apr 2021
- Primary completion15 Jun 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide and DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar H Trivedi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783506
- Sponsor's protocol ID
- STU-2020-1297
- Status last verified
- Dec 2025
- First submitted
- 25 Feb 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Inflammatory Profiles and Suicidal Behavior in Adolescents
- ClinicalTrials.gov ID
- NCT04783506
- Acronym / sponsor ID
- STU-2020-1297
- Conditions
- Suicide and Depression
- Keywords
- suicide attempt, suicidal behavior, healthy control, adolescent, observational, depression, suicidal idation, suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to map inflammatory dysfunction to suicidal behavior and establish a reliable immune signature of suicide risk that can 1) guide future research into fundamental pathophysiology and 2) identify targets for drug development and guide clinical screening and risk management.
Background: In previous research, the investigators have identified targets of clinical utility for both suicide-risk identification and novel therapeutic development. Specifically, a state of immune hyper-reactivity that predisposes to suicidal behavior can be corrected by use of immunomodulatory agents.
Blood tests screening for presence of autoantibodies may be implemented as diagnostic tests to predict future suicide risk. Monoclonal antibodies have gained recent attention for their use in CNS disorders (such as multiple sclerosis and migraine) and have been shown to be effective for some patients with depression.
However, the utility of anti-inflammatory treatments for depression has been limited by a lack of biomarkers to guide their use. Thus, presence of autoantibodies may identify a sub-group of adolescents and young adults with suicidality who are candidates for treatment with monoclonal antibodies.
The investigators specifically hypothesize that depressed youths with suicide behavior have immune hyper-reactivity, as reflected in dysfunctional cells mediating both innate and adaptive immune response.
Study Items: Since this is an observational study, investigators will explore a comprehensive panel of carefully selected participant specific parameters: socio-demographic (age, ethnicity, economic); symptom severity measures (depressive symptoms, mood, and feelings); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood), behavioral (cognitive, emotional), with the goal to develop the most robust predictive models of treatment response and of depression outcomes. There is no medication or non-medication treatment or intervention provided by this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suicidal Behavior | – | Other: Observational StudyAdolescents 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. |
| At Risk for Mood Disorders | – | Other: Observational StudyAdolescents 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. |
| Healthy Control | – | Other: Observational StudyHealthy 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational StudyThere is no intervention provided by this study. Observed for 12-month period using questionnaires and study visits. | Other | At Risk for Mood Disorders, Healthy Control, Suicidal Behavior |
Primary outcome
Comprehensively characterize inflammatory tone and response
Time frame: Baseline
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.
1 secondary outcome
Quantify levels of autoantibodies
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar H Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensively characterize inflammatory tone and response (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.