Suicidality in children and adolescents

ISRCTN	ISRCTN16781226
DOI	https://doi.org/10.1186/ISRCTN16781226
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	VEGA 1/0183/24
Sponsor	Grant Agency of the Ministry of Education, science, research and sport of the Slovak Republík and the Slovak Academy of Science
Funder	Univerzita Komenského v Bratislave

Submission date: 29/01/2025
Registration date: 16/06/2025
Last edited: 16/06/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In 2021, there was a 72% increase in suicides among 15-19-year-olds in Slovakia. This study aims to understand the relationship between suicidal thoughts and attempts and psychiatric diagnoses in children. It will also explore the impact of COVID-19 on these issues and identify potential predictors of suicidal behavior.

Who can participate?
Children and adolescents aged 10-17 years with suicidal thoughts or a history of suicide attempts in the last 7 days, who are registered at the Department of Paediatric Psychiatry of the Faculty of Medicine of the Comenius University and the National Institute of Children’s Diseases in Bratislava. The control group will include 20 healthy volunteers not under psychiatric or psychological care.

What does the study involve?
Participants will fill out self-report questionnaires. An examiner will assess the severity of depressive symptoms and suicide risk using objective scales. Biological samples (blood, urine, hair) will be collected from both patients and healthy controls, processed using standard clinical methods, and stored at -80°C.

What are the possible benefits and risks of participating?
Participants may benefit from the detection of biomarkers not included in standard examinations. The only recorded risk is minor bruising from blood sample collection.

Where is the study run from?
The study will be conducted at the Department of Paediatric Psychiatry at Comenius University, Faculty of Medicine in Bratislava, and the National Institute of Children’s Diseases in Bratislava, Slovakia.

When is the study starting and how long is it expected to run for?
April 2024 to December 2027.

Who is funding the study?
The study is funded by the Grant Agency of the Ministry of Education, Science, Research, and Sport of the Slovak Republic and the Slovak Academy of Science.

Who is the main contact?
Dr Jana Trebatická, jana.trebaticka@fmed.uniba.sk

Contact information

Dr Jana Trebatická
Public, Scientific, Principal investigator

Limbová 1
Bratislava
83340
Slovakia

ORCID ID	0000-0001-5111-4612
Phone	+421 905560219
Email	jana.trebaticka@fmed.uniba.sk

Study information

Primary study design	Observational
Study design	Single-center observational case-control study
Secondary study design	Case-control study
Participant information sheet	46766 PIS informed consent in Slovak.pdf
Scientific title	Suicidality in children and adolescents, neurobiological parameters, and their mutual association.
Study acronym	NeuroSui
Study objectives	1. Determination of the prevalence of suicidal ideation and suicide attempts in children and adolescents hospitalized in pedopsychiatric inpatient wards concerning psychiatric diagnoses. 2. To determine neurobiological correlates with the focus on inflammatory markers (CRP, the neutrophil-to-lymphocyte ratio, fibrinogen, orosomucoid, neopterin), lipid profile (total cholesterol, LDLand HDLcholesterol, subfractions of HDL lipoproteins, cortisol, markers of oxidative and nitrosylation stresses (nitrotyrosine, lipoperoxides, 8isoprostanes, AOPP, activity of glutathione peroxidase, catalase, SOD, glutamyl cysteinyl ligase (GCL), proteins of Nrf2/Keap1/ARE signaling pathway and total plasma antioxidant capacity) in the child and adolescent patients with suicidal ideations and after suicide attempts compared to a control group of healthy children. 3. Determine the correlations between established neurobiological markers and psychopathological factors (incidence of suicidal ideation/suicide attempts, severity of depressive symptoms, presence of adverse life event) concerning age, gender, and diagnosis, and identify a potential predictive marker for use in clinical practice based on the results. 4. Investigate a potential relationship between overcoming a COVID-19 infection and the incidence of suicidal ideation and suicide attempts and neurobiological markers.
Ethics approval(s)	1. Approved 23/04/2024, Ethics Committee of the National Institute of Children’s Diseases and the Faculty of Medicine, Comenius University Bratislava (Limbová 1, Bratislava, 83340, Slovakia; +421 259371209; detska.klinika@nudch.eu), ref: EK4/1/2024 2. Approved 17/09/2024, Ethics Committee of the National Institute of Children’s Diseases and the Faculty of Medicine, Comenius University Bratislava (Limbová 1, Bratislava, 83340, Slovakia; +421 259371209; detska.klinika@nudch.eu), ref: EK9/2/2024
Health condition(s) or problem(s) studied	Incidence of suicide attempts in the last seven days, Incidence of suicidal ideations.
Intervention	The research group will consist of 60 patients who will be divided into two groups: patients with suicidal ideations (SI) and patients after suicide attempts (SA). The enrolled patients will be asked to fill out the following scales: the self-report Symptom Checklist 90 (SCL90R), the Child Depression Inventory (CDI) self-report questionnaire, and the self-report Yale Vermont Adversity in Childhood Scale (Y-VACS-SR) The examiner will investigate depressive symptoms severity using the Children's Depression Rating Scale-Revised (CDRS-R) and suicide risk using the Columbia Suicide Severity Rating Scale (C-SSRS). Biological material (blood, urine, hair) of patients and healthy controls will be collected, processed using standard clinical biochemistry methods, and stored at -80° C.
Intervention type	Other
Primary outcome measure(s)	1. Prevalence of suicidal ideation is measured using the self-report Symptom Checklist 90 (SCL90R) at a single time point 2. Prevalence of suicide attempts is measured using the self-report Symptom Checklist 90 (SCL90R) at a single time point 3. Depressive symptoms severity is measured using the Children's Depression Rating Scale Revised (CDRSR) at a single time point 4. Suicide risk is measured using the Columbia Suicide Severity Rating Scale (CSSRS) at a single time point 5. Depressive symptoms in children and adolescents are measured using the Child Depression Inventory (CDI) self-report questionnaire at a single time point 6. Childhood adversity is measured using the self-report Yale Vermont Adversity in Childhood Scale (YVACSSR) at a single time point 7. Impact of COVID-19 on mental health is measured using the self-report COVID-19 Yorkshire Rehabilitation Scale (C19YRS) at a single time point 8. Mental health evaluation in healthy controls is measured using the Children's Depression Rating Scale Revised (CDRSR) at a single time point
Key secondary outcome measure(s)	1. Total cholesterol is measured using standard methods in a commercial clinical laboratory at a single time point 2. LDL cholesterol is measured using standard methods in a commercial clinical laboratory at a single time point 3. HDL cholesterol is measured using standard methods in a commercial clinical laboratory at a single time point 4. ApoA is measured using standard methods in a commercial clinical laboratory at a single time point 5. ApoE is measured using standard methods in a commercial clinical laboratory at a single time point 6. hsCRP is measured using standard methods in a commercial clinical laboratory at a single time point 7. IL6 is measured using standard methods in a commercial clinical laboratory at a single time point 8. IL2 is measured using standard methods in a commercial clinical laboratory at a single time point 9. Fibrinogen is measured using standard methods in a commercial clinical laboratory at a single time point 10. Orosomucoid is measured using standard methods in a commercial clinical laboratory at a single time point 11. Neutrophil count is measured using standard methods in a commercial clinical laboratory at a single time point 12. Lymphocyte count is measured using standard methods in a commercial clinical laboratory at a single time point 13. Neutrophil to lymphocyte ratio is measured using standard methods in a commercial clinical laboratory at a single time point 14. LDL subfractions are measured using the Lipoprint system at a single time point 15. HDL subfractions are measured using the Lipoprint system at a single time point 16. BDNF is measured using Elisa kit at a single time point 17. Nrf2 is measured using Elisa kit at a single time point 18. Lipoperoxides are measured using spectrophotometry at a single time point 19. AOPP is measured using spectrophotometry at a single time point 20. Catalase activity is measured using spectrophotometry at a single time point 21. SOD activity is measured using kits in erythrocyte hemolysate at a single time point 22. GPx activity is measured using kits in erythrocyte hemolysate at a single time point 23. Total antioxidant capacity of plasma is measured using spectrophotometry at a single time point 24. GCL is measured using western blot (WB) at a single time point 25. Protein expression of antioxidant enzymes is measured using western blot (WB) at a single time point 26. Cortisol in hair is measured using commercial kits at a single time point 27. 8 isoprostanes in urine are measured using commercial kits at a single time point 28. Creatinine in urine is measured using commercial kits at a single time point 29. Signaling pathway proteins are measured using western blot (WB) at a single time point 30. Gene expression is measured using RT PCR at a single time point 31. Protein concentration is measured using the Western Blot method at a single time point 32. mRNA level is measured using the qRT-PCR method at a single time point 33. Lipoprotein subfractions are measured using the Lipoprint method at a single time point
Completion date	31/12/2027

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Patients hospitalized at the Department of Paediatric Psychiatry of the Comenius University, Medical Faculty and the National Institute of Children's Diseases, age 10-17 years. 2. Signed informed consent by the legal guardian. 3. Verbal consent of the patient to be included in the project. 4. Presence of suicidal ideation and/or suicide attempts. 5. Children and adolescents are willing to provide blood, urine, and hair samples.
Key exclusion criteria	Chronic somatic inflammatory and oncological disease
Date of first enrolment	01/02/2025
Date of final enrolment	30/06/2027

Locations

Countries of recruitment

Slovakia

Study participating centre

The National Institute of Children's Diseases

Limbová 1
Bratislava
83340
Slovakia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request after the project is completed from Jana Trebatická, jana.trebaticka@fmed.uniba.sk

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	in Slovak		12/02/2025	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file			12/02/2025	No	No

Additional files

46766 Protocol.pdf: Protocol file
46766 PIS informed consent in Slovak.pdf: in Slovak

Editorial Notes

29/01/2025: Trial's existence confirmed by Ethics Committee of the National Institute of Children’s Diseases and the Faculty of Medicine, Comenius University Bratislava.