Biomarkers as Predictors of Suicidal Risk in Adolescents

NCT03014518 | Completed

• 2 other identifiers: 16-630MH108857
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suicide, Attempted; Suicidal Ideation; Suicidal Intention; Suicide

Keywords

Adolescent; Biological Markers; Biomarkers; Biomarkers for suicidality; Blood brain barrier; Clinical predictors; Cytokine; Feeling suicidal; Inflammation; Inflammatory marker; Inpatient discharge; Interleukin-1 beta; IL-1ß; Interleukin-6; IL-6; Kynurenic acid; Kynurenine pathway; Neuroinflammation; Novel marker; Peripheral blood biomarkers; Picolinic acid; Plasma biomarker; Psychiatric inpatient; S100B; Serum biomarker; Stress; Suicide; Suicidal behavior; Suicidal risk; Tumor necrosis factor alpha; TNF-α

Outcome Measures

Primary Outcomes (2)

• Relation between levels of peripheral inflammatory markers and suicide attempt

  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

  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 Outcomes (25)

• Change from baseline in peripheral inflammatory marker levels for healthy control group

  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

  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

  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

  on the date of discharge from hospital inpatient unit (average length of admission = 5 days)

• Relation between levels of peripheral inflammatory markers and depression

  on the date of discharge from hospital inpatient unit (average length of admission = 5 days)

Study Arms (2)

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

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

Interventions

Clinical assessments and blood samples; follow-up for 12 mos OTHER

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.

Suicide Attempt Study Group

Clinical assessments and blood samples; no 12mo follow-up OTHER

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).

Healthy Control Group

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

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.

You may qualify if:

• Suicide Attempt Study Group:
• years of age
• admitted to the Cleveland Clinic inpatient child and adolescent psychiatry unit after suicidal ideations or a suicide attempt
• Healthy Control Group:
• years of age
• No history of suicide attempt

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Case Western Reserve University: collaborator
• Van Andel Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation; Suicide; Inflammation; Neuroinflammatory Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tatiana Falcone, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, Cleveland Clinic

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: January 9, 2017
• Study Start: December 1, 2016
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)