Biomarkers as Predictors of Suicidal Risk in Adolescents

July 15, 2021 updated by: Tatiana Falcone, MD, The Cleveland Clinic

Peripheral Neuroinflammatory Predictors of Suicidal Risk at Time of Inpatient Discharge in Adolescents

Suicide is one of the most devastating events in society at all levels. The primary goal of this study is to predict suicide in adolescents at risk. We will utilize blood biomarker measurement and clinical risk factor scales to develop a tool to identify adolescents at risk for suicide earlier, which will allow clinicians to prescribe timely treatment and prevent suicide.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Suicide, the second leading cause of death in adolescents (15-24 year olds), is the most tragic complication of a psychiatric condition in this age group. Every year, approximately 157,000 youth receive medical care for suicide related injuries at emergency departments throughout the U.S. Despite some progress, suicide prevention continues to be a daunting task. In adolescents, the risk of a second suicide attempt is approximately 30% after discharge from an inpatient psychiatric unit. Up to 80% of suicidal patients who subsequently died by suicide deny suicidal ideation in their last communication with a health care provider. Therefore, there is an urgent need for the development of biomarkers that can objectively identify which youth are most likely to engage in subsequent suicide attempts.

Several lines of evidence (postmortem studies, genetic studies, biomarker studies) as well as preliminary studies conducted by our group have pointed to neuroinflammation as one of the neurobiological findings observed in suicidal behavior. In particular, the principal investigator and co- investigators have identified S100B - an astrocytic protein, which is a marker of blood brain barrier (BBB) impairment, as a novel biomarker associated with suicidality in adolescents. We are now also investigating three additional and important markers Kynurenic Acid (KYNA), Quinolinic Acid (QUIN), and Picolinic Acid (PIC) identified by Dr. Lena Brundin (Van Andel Institute) to be altered in patients after a suicide attempt. Other studies have reported several other peripheral inflammatory markers (PlMs) including interleukin-1 beta (IL-1ß), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) as associated with suicidality. Hence, PlMs either on their own or along with clinical markers may be particularly useful in predicting future suicide attempts. This study will investigate whether PIM levels, with or without clinical predictors, can be useful at the time of discharge from an inpatient psychiatric unit to predict suicidality in adolescent patients in the subsequent 12 months. The first aim of this study is to determine whether plasma levels of S100B, IL-1ß, IL-6, TNF-α, KYNA, QUIN, and PIC correlate with suicidal behavior (SB). Secondly, this study will investigate if any of the PlMs can predict suicidal attempts. Finally, we will test which combination of clinical risk factors and PlMs is able to most efficiently predict SB post-discharge from the inpatient unit.

Innovative aspects of this study include: 1) The first study to longitudinally investigate levels of PlMs at the time of admission and their change at the time of discharge in adolescent patients being admitted for SB. 2) The first study to investigate whether level of PIMS (alone or in combination with clinical risk factors) at the time of discharge can predict readmissions for SB in the next 12 months. 3) Beside the well-studied PIMs in adult samples, specifically investigate novel biomarkers of inflammation- S100B and 3 markers of the Kynurenine pathway (KYNA, QUIN and PIC).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The suicide attempt study group will be recruited from all patients (ages 12-18 years) admitted to the Cleveland Clinic inpatient child and adolescent psychiatry unit after a suicide attempt. Healthy adolescent control group (ages 12-18 years) will be recruited through the Cleveland Clinic pediatric outpatient offices.

Description

Inclusion Criteria:

Suicide Attempt Study Group:

  • 12-18 years of age
  • admitted to the Cleveland Clinic inpatient child and adolescent psychiatry unit after suicidal ideations or a suicide attempt

Healthy Control Group:

  • 12-18 years of age
  • No history of suicide attempt

Exclusion Criteria:

Suicide Attempt Study Group:

  • History of autism spectrum disorder
  • Non-verbal
  • Moderate or severe intellectual disability (IQ<70 and patients in special education full-time)
  • Schizophrenia or schizoaffective disorder diagnosis
  • Current diagnosis of anorexia or bulimia
  • History of generalized tonic-clonic epileptic seizures in last 3 months (If patient does not have a history of seizures, and generalized tonic-clonic seizure was clinically determined to be caused by patient's recent overdose attempt, patient can still be recruited for study if 24 hours has passed since last seizure)
  • History of traumatic brain injury, brain tumor, or any major neurological disorder
  • Delirium or mood disorder secondary to general medical condition
  • Current infection, fever, antibiotic use in the last 2 weeks
  • History of autoimmune or immunodeficiency diseases
  • Current untreated major endocrine disorder
  • Current pregnancy or delivery within the last month
  • Diagnosed malnutrition
  • Positive urine toxicology for benzodiazepines or opiates on admission
  • Current substance use disorder diagnosis and referral for CD assessment upon discharge
  • Current diagnosis of morbid obesity or a current BMI greater than 40 kg/m2
  • Abnormal complete blood count (CBC)

Healthy Control Group:

  • History of any psychiatric diagnosis / treatment (behavioral diagnoses [ADD/ADHD/etc] are okay)
  • History of suicidal ideation, behavior, or attempt
  • Family history of suicide attempts
  • Diagnosis of schizophrenia or bipolar disorder in parents or siblings
  • History of autism spectrum disorder
  • Moderate or severe intellectual disability (IQ<70 and patients in special education full-time)
  • History of generalized tonic-clonic epileptic seizures in last 3 months
  • History of headaches or migraines in the last month
  • History of traumatic brain injury, brain tumor, or any major neurological disorder
  • Delirium or mood disorder secondary to general medical condition
  • Current infection, fever, antibiotic use in the last 2 weeks
  • History of autoimmune or immunodeficiency diseases
  • Current untreated major endocrine disorder
  • Current pregnancy or delivery within the last month
  • Diagnosed malnutrition
  • Report of any substance use in week prior

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Suicide Attempt Study Group
Adolescents admitted to the Cleveland Clinic inpatient child and adolescent psychiatry unit after suicide attempt. Clinical assessments and blood samples; follow-up for 12 mos.
Other: Clinical assessments and blood samples; follow-up for 12 mos
Kiddie-Sads Present and Lifetime Version Diagnostic Interview, Columbia-Suicide Severity Rating Scale, Suicidal Ideation Questionnaire, Children's Depression Rating Scale-Revised, Multidimensional Anxiety Scale for Children (2nd Ed), Adverse Childhood Experiences Questionnaire, Life Events Checklist-5, Pubertal Development Scale. All assessments administered at baseline, and a smaller subset of assessments administered at discharge and other time points throughout 12 months follow-up. Blood samples taken at baseline (admission to unit) and day of discharge.
Healthy Control Group
Healthy adolescents with no history of suicide attempt. Clinical assessments and blood samples; no 12mo follow-up.
Other: Clinical assessments and blood samples; no 12mo follow-up
Kiddie-Sads Present and Lifetime Version Diagnostic Interview, Columbia-Suicide Severity Rating Scale, Suicidal Ideation Questionnaire, Children's Depression Rating Scale-Revised, Multidimensional Anxiety Scale for Children (2nd Ed), Adverse Childhood Experiences Questionnaire, Life Events Checklist-5, Pubertal Development Scale. All assessments administered at baseline, and a smaller subset of assessments administered at discharge time point (5-7 days after baseline). Blood samples taken at baseline and discharge time points (5-7 days after baseline).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relation between levels of peripheral inflammatory markers and suicide attempt
Time Frame: baseline
Comparison of the levels of peripheral inflammatory markers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) between participants with and without suicide attempt
baseline
Relation between levels of peripheral inflammatory markers and suicide attempt
Time Frame: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Comparison of the levels of peripheral inflammatory markers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) between participants with and without suicide attempt
on the date of discharge from hospital inpatient unit (average length of admission = 5 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in peripheral inflammatory marker levels for healthy control group
Time Frame: baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Comparison of the levels of peripheral inflammatory markers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) between baseline and discharge time points
baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Change from baseline in peripheral inflammatory marker levels for suicide attempt study group
Time Frame: baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Comparison of the levels of peripheral inflammatory markers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) between baseline and discharge time points
baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and Columbia Suicide Severity Rating Scale scores
Time Frame: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Studying relation between inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) and suicide ideation intensity (scores on Columbia Suicide Severity Rating Scale)
on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and Suicidal Ideation Questionnaire scores
Time Frame: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Studying relation between inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) and suicide ideation intensity (Suicidal Ideation Questionnaire)
on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and depression
Time Frame: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Studying relation between inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) and depression (scores on Children's Depression Rating Scale, Revised)
on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and anxiety
Time Frame: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Studying relation between inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) and anxiety (scores on Multidimensional Anxiety Scale for Children, 2nd Ed)
on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and trauma
Time Frame: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Studying relation between inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) and trauma (scores on Adverse Childhood Experiences Questionnaire (ACE) and Life Events Checklist-5 (LEC-5))
on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Changes in peripheral inflammatory marker levels predicting changes in Columbia Suicide Severity Rating Scale scores
Time Frame: baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Peripheral inflammatory markers: S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid
baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Changes in peripheral inflammatory marker levels predicting changes in Suicidal Ideation Questionnaire scores
Time Frame: baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Peripheral inflammatory markers: S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid
baseline and on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Peripheral inflammatory markers as a risk factor for suicide attempts
Time Frame: up to 12 months post-discharge
Studying inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide attempt risk factors (frequency of attempts)
up to 12 months post-discharge
Peripheral inflammatory markers as a risk factor for suicide ideation intensity (scores on Columbia Suicide Severity Rating Scale)
Time Frame: up to 12 months post-discharge
Studying inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide ideation intensity risk factors (scores on Columbia Suicide Severity Rating Scale)
up to 12 months post-discharge
Peripheral inflammatory markers as a risk factor for suicide ideation intensity (scores on Suicidal Ideation Questionnaire)
Time Frame: up to 12 months post-discharge
Studying inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide ideation intensity risk factors (scores on Suicidal Ideation Questionnaire)
up to 12 months post-discharge
Peripheral inflammatory markers as a risk factor for suicide attempt re-admission
Time Frame: up to 12 months post-discharge
Studying inflammatory biomarkers (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide attempt re-admission risk factors (frequency of re-admissions)
up to 12 months post-discharge
Change in peripheral inflammatory marker levels from baseline to discharge as a risk factor for suicide attempts
Time Frame: up to 12 months post-discharge
Studying the change in inflammatory biomarkers from baseline to discharge (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide attempt risk factors (frequency of attempts)
up to 12 months post-discharge
Change in peripheral inflammatory marker levels from baseline to discharge as a risk factor for suicide ideation intensity (scores on Columbia Suicide Severity Rating Scale)
Time Frame: up to 12 months post-discharge
Studying the change in inflammatory biomarkers from baseline to discharge (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide ideation intensity risk factors (scores on Columbia Suicide Severity Rating Scale)
up to 12 months post-discharge
Change in peripheral inflammatory marker levels from baseline to discharge as a risk factor for suicide ideation intensity (scores on Suicidal Ideation Questionnaire)
Time Frame: up to 12 months post-discharge
Studying the change in inflammatory biomarkers from baseline to discharge (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide ideation intensity risk factors (scores on Suicidal Ideation Questionnaire)
up to 12 months post-discharge
Change in peripheral inflammatory marker levels from baseline to discharge as a risk factor for suicide attempt re-admission
Time Frame: up to 12 months post-discharge
Studying the change in inflammatory biomarkers from baseline to discharge (S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid) as suicide attempt re-admission risk factors (frequency of re-admissions)
up to 12 months post-discharge
Clinical assessment values that predict suicide attempts
Time Frame: up to 12 months post-discharge
Studying which clinical assessments can help predict suicide attempt (frequency of attempts)
up to 12 months post-discharge
Clinical assessment values that predict suicide ideation intensity scores on Columbia Suicide Severity Rating Scale
Time Frame: up to 12 months post-discharge
Studying which clinical assessments can help predict suicide ideation intensity scores on Columbia Suicide Severity Rating Scale
up to 12 months post-discharge
Clinical assessment values that predict suicide ideation intensity scores on Suicidal Ideation Questionnaire
Time Frame: up to 12 months post-discharge
Studying which clinical assessments can help predict suicide ideation intensity scores on Suicidal Ideation Questionnaire
up to 12 months post-discharge
Clinical assessment values that predict suicide attempt re-admission
Time Frame: up to 12 months post-discharge
Studying which clinical assessments can help predict suicide attempt re-admission (frequency of re-admissions)
up to 12 months post-discharge
Peripheral inflammatory markers in combination with clinical assessments as predictors for suicide attempts
Time Frame: up to 12 months post-discharge
Studying which combination of inflammatory biomarkers and clinical predictors best predicts future suicide attempts (frequency of attempts)
up to 12 months post-discharge
Peripheral inflammatory markers in combination with clinical assessments as predictors for suicide ideation intensity scores on Columbia Suicide Severity Rating Scale
Time Frame: up to 12 months post-discharge
Studying which combination of inflammatory biomarkers and clinical predictors best predicts suicide ideation intensity scores on Columbia Suicide Severity Rating Scale
up to 12 months post-discharge
Peripheral inflammatory markers in combination with clinical assessments as predictors for suicide ideation intensity scores on Suicidal Ideation Questionnaire
Time Frame: up to 12 months post-discharge
Studying which combination of inflammatory biomarkers and clinical predictors best predicts suicide ideation intensity scores on Suicidal Ideation Questionnaire
up to 12 months post-discharge
Peripheral inflammatory markers in combination with clinical assessments as predictors for suicide attempt re-admission
Time Frame: up to 12 months post-discharge
Studying which combination of inflammatory biomarkers and clinical predictors best predicts future suicide attempt re-admissions (frequency of re-admissions)
up to 12 months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Case Western Reserve University
Van Andel Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-630
  • MH108857 (OTHER_GRANT: NIMH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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