Suicide, AttemptedNCT03014518
Biomarkers as Predictors of Suicidal Risk in Adolescents
An observational study of Suicide, Attempted and Suicidal Ideation, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation, Suicidal Intention
- What is being tested?
- Clinical assessments and blood samples; follow-up for 12 mos and Clinical assessments and blood samples; no 12mo follow-up
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 28 Jun 2021
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 35Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Suicide, Attempted, Suicidal Ideation, Suicidal Intention, Suicide
- Being tested
- Clinical assessments and blood samples; follow-up for 12 mos, Clinical assessments and blood samples; no 12mo follow-up
- 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
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation, Suicide, Inflammation, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessments and blood samples; follow-up for 12 mosOther
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.
Clinical assessments and blood samples; no 12mo follow-upOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Clinical assessments and blood samples; no 12mo follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: 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
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
Measured: 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
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)
Measured: 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
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)
Measured: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and depression
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)
Measured: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and anxiety
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)
Measured: on the date of discharge from hospital inpatient unit (average length of admission = 5 days)
Relation between levels of peripheral inflammatory markers and trauma
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))
Measured: 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
Peripheral inflammatory markers: S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid
Measured: 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
Peripheral inflammatory markers: S100B, IL-6, IL-1β, TNF-α, kynurenic acid, quinolinic acid, and picolinic acid
Measured: 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
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)
Measured: up to 12 months post-discharge
Peripheral inflammatory markers as a risk factor for suicide ideation intensity (scores on Columbia Suicide Severity Rating Scale)
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)
Measured: up to 12 months post-discharge
Peripheral inflammatory markers as a risk factor for suicide ideation intensity (scores on Suicidal Ideation Questionnaire)
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)
Measured: up to 12 months post-discharge
Peripheral inflammatory markers as a risk factor for suicide attempt re-admission
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)
Measured: up to 12 months post-discharge
Change in peripheral inflammatory marker levels from baseline to discharge as a risk factor for suicide attempts
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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
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)
Measured: up to 12 months post-discharge
Clinical assessment values that predict suicide attempts
Studying which clinical assessments can help predict suicide attempt (frequency of attempts)
Measured: up to 12 months post-discharge
Clinical assessment values that predict suicide ideation intensity scores on Columbia Suicide Severity Rating Scale
Studying which clinical assessments can help predict suicide ideation intensity scores on Columbia Suicide Severity Rating Scale
Measured: up to 12 months post-discharge
Clinical assessment values that predict suicide ideation intensity scores on Suicidal Ideation Questionnaire
Studying which clinical assessments can help predict suicide ideation intensity scores on Suicidal Ideation Questionnaire
Measured: up to 12 months post-discharge
Clinical assessment values that predict suicide attempt re-admission
Studying which clinical assessments can help predict suicide attempt re-admission (frequency of re-admissions)
Measured: up to 12 months post-discharge
Peripheral inflammatory markers in combination with clinical assessments as predictors for suicide attempts
Studying which combination of inflammatory biomarkers and clinical predictors best predicts future suicide attempts (frequency of attempts)
Measured: 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
Studying which combination of inflammatory biomarkers and clinical predictors best predicts suicide ideation intensity scores on Columbia Suicide Severity Rating Scale
Measured: 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
Studying which combination of inflammatory biomarkers and clinical predictors best predicts suicide ideation intensity scores on Suicidal Ideation Questionnaire
Measured: up to 12 months post-discharge
Peripheral inflammatory markers in combination with clinical assessments as predictors for suicide attempt re-admission
Studying which combination of inflammatory biomarkers and clinical predictors best predicts future suicide attempt re-admissions (frequency of re-admissions)
Measured: up to 12 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Van Andel Research Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tatiana Falcone, MD, The Cleveland Clinic
- Investigators
- Tatiana Falcone, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014518
- Sponsor's protocol ID
- 16-630
- Other IDs
- MH108857
- Status last verified
- Jul 2021
- First submitted
- 15 Dec 2016
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Neuroinflammatory Predictors of Suicidal Risk at Time of Inpatient Discharge in Adolescents
- ClinicalTrials.gov ID
- NCT03014518
- Acronym / sponsor ID
- 16-630
- Conditions
- Suicide, Attempted, Suicidal Ideation, Suicidal Intention, Suicide
- Keywords
- Adolescent, Biological Markers, Biomarkers, Biomarkers for suicidality, Blood brain barrier, Clinical predictors, Cytokine, Feeling suicidal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Van Andel Research Institute, National Institute of Mental Health (NIMH)
- Study start
- Dec 2016 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 9 Jan 2017 (estimated)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicide Attempt Study Group | – | Other: Clinical assessments and blood samples; follow-up for 12 mosAdolescents admitted to the Cleveland Clinic inpatient child and adolescent psychiatry unit after suicide attempt. Clinical assessments and blood samples; follow-up for 12 mos. |
| Healthy Control Group | – | Other: Clinical assessments and blood samples; no 12mo follow-upHealthy adolescents with no history of suicide attempt. Clinical assessments and blood samples; no 12mo follow-up. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 12-18 years of age
- admitted to the Cleveland Clinic inpatient child and adolescent psychiatry unit after suicidal ideations or a suicide attempt
- 12-18 years of age
- No history of suicide attempt
Key exclusion criteria (35 listed)
- 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
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 |
|---|---|---|
| Clinical assessments and blood samples; follow-up for 12 mosKiddie-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. | Other | Suicide Attempt Study Group |
| Clinical assessments and blood samples; no 12mo follow-upKiddie-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). | Other | Healthy Control Group |
Primary outcome
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
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
25 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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 as a risk factor for suicide attempts
Time frame: 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
Peripheral inflammatory markers as a risk factor for suicide ideation intensity (scores on Suicidal Ideation Questionnaire)
Time frame: 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
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
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
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
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
Clinical assessment values that predict suicide attempts
Time frame: 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
Clinical assessment values that predict suicide ideation intensity scores on Suicidal Ideation Questionnaire
Time frame: up to 12 months post-discharge
Clinical assessment values that predict suicide attempt re-admission
Time frame: 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
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
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
Peripheral inflammatory markers in combination with clinical assessments as predictors for suicide attempt re-admission
Time frame: up to 12 months post-discharge
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 16 Jul 2021.
- Individual participant dataSharing planned: No
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Suicide
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.
Tatiana Falcone, M.D. principal investigator
The Cleveland Clinic
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, Attempted and Suicidal Ideation, run by The Cleveland Clinic 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 6 inclusion and 35 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 16 Jul 2021. 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?
Relation between levels of peripheral inflammatory markers and suicide attempt (time frame: baseline). The study lists 2 primary outcomes in all. 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 16 Jul 2021.