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Short-chain carnitines as potential biomarkers in depressed adolescents and their associations with aberrant (neuro)immunological and endocrinological parameters

Short-chain carnitines as potential biomarkers in depressed adolescents and their associations with aberrant (neuro)immunological and endocrinological parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030637
Enrollment
70
Registered
2022-11-02
Start date
2023-02-21
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32 F33

Interventions

Group 1: patient cohort (PC): Adolescents diagnosed with depressive disorder For the initial psychiatric characterization of the subjects, we first conduct the Mini-International Neuropsychiatric Int
with the help of individual items of the AtR!Sk-Baseline Interview, version 3), a comprehensive, questionnaire-based characterization of the study participants is carried out in terms of - anamnestic
o positive family history (1st and 2nd generation level) regarding depressive disorders
o psychiatric comorbidities outside of the exclusion criteria
o adverse childhood experiences (ACE)
Evaluation using Childhood Experiences of Care and Abuse (CECA)
o classification of individual stress burden using Perceived Stress Scale (PSS)
o average weekly physical activity
objectifying assessment using International Physical Activity Questionnaire (IPAQ) [short last 7 days self-administered format]. - anthropometric data such as height, weight and BMI
- psychometric-psychiatric-behavioral variables such as o depressive symptom severity and characteristics
Evaluation by means of Beck's Depression Inventory II (BDI-II) [minus items, related to sexual (er)life]. o the degree of severity as well as the characteristics of somatic symptomatology
Evaluation by means of Patient Health Questionnaire - 15 (PHQ-15)
o non-suicidal self-injurious behaviors (NSSV)
Assessment using Self-Injurious Thoughts and Behavior Interview (SITBI) [Abstract]
o a standardized clinical-psychiatric

Sponsors

Lehrstuhl für Kinder- und Jugendpsychiatrie und -psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg (medbo)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 18 Years

Inclusion criteria

Inclusion criteria: - Sufficient comprehension of the German language - Patient Cohort (PC): Fulfillment of ICD-10 criteria regarding the classification of depressive disorders under F32. or F33. or F43.21 based on expert judgment; In addition, fulfillment of the Major Depressive Disorder criteria in the MINI-Kid (Mini-International Neuropsychiatric Interview for Children and Adolescents). - Patient Cohort (PC): Outpatient, partial or full inpatient connection within the child/adolescent psychiatric care network either at the Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy (KJPP) of the University of Regensburg at the District Clinic Regensburg or at the child and adolescent psychiatric as well as social psychiatric practice Dr. med Matthias Niebler in Neumarkt/Opf. - Informed consent of the test persons and their legal guardians

Exclusion criteria

Exclusion criteria: - Acute neurological or somatic diseases with long-term influence on endocrinological, metabolic or inflammatory regulatory circuits, which occurred less than six months ago - Pre-existing chronic endocrinologic, neurologic, autoimmune, or autoinflammatory diseases - Acute febrile flu-like infections with fever at the time of blood draw - medically confirmed needle phobia - psychiatric comorbidities with a high burden of disease and severe manifestations, specifically clinical pictures such as schizophrenia, autism spectrum disorders (ASD), Borderline Personality Disorder (BPD) and eating disorders requiring inpatient treatment - Acute psychiatric condition that could impair the patient's/proband's ability to give consent - Consumption of substances listed in the current (as of 08/2022) version of the BtMG within the last four weeks - Harmful (ICD-10: F10.1) alcohol intake within the last four weeks or abusive (ICD-10: F10.2) alcohol consumption within the last three months - Harmful (ICD-10: F17.1) tobacco consumption within the past four weeks or abusive (ICD-10: F17.2) tobacco consumption within the past three months - Consumption of alcohol or nicotine in the last 24 h before blood sampling - Long-term pharmacotherapy with antidepressant intent, discontinuation of which was less than three months ago - Long-term therapy (> 1 month) less than four weeks ago with pharmaceuticals that exert influence on metabolome, endocrine or inflammatory axis, especially systemic steroid therapy, statin therapy, therapy with immunomodulatory/immunosuppressive pharmaceuticals; Exception: hormonal contraception - current anti-infective therapy at the time of blood collection - Pregnancy - Known intellectual impairment (IQ<80) - lack of consent

Design outcomes

Primary

MeasureTime frame
Is a decrease in L-acetyl-carnitine (LAC) levels statistically significantly associated with the group variable 'subject with depression (PC)' compared to a healthy control group (HC)?

Secondary

MeasureTime frame
1) Within the PC cohort, is there a correlation between (lowered) LAC levels and 'depressive symptom severity' (assessed by BDI-II) and/or 'severity of somatic symptomatology' (assessed psychometrically by PHQ-15)? 2) Do both cohorts (PC and HC) display decreased LAC scores significantly associated with the subgroup variables 'positive family history'; 'presence of adverse childhood events (ACE)' (psychometric assessment by CECA); 'suicidality' (assessment by BDI-II and SITBI) ; 'non-suicidal self-injurious behavior' (NSSV) (assessed by SITBI); 'stress level' (assessed by PSS); 'clinical psychiatric global assessment' (assessed by CGI); 'psychosocial functioning level' (assessed by GAF)? 3) Can the specific alterations found in recent evidence within the inflammatory (increased basal inflammation level, CRP and IL-6 as indicator variables) as well as within the endocrinological axis (HPA disinhibition, ACTH, cortisol, DHEA-S as indicator variables) in adolescent depressive disorders compared to healthy controls also be reproduced in our depressive cohort (PC)? 4) Do correlations between elevated inflammatory parameters (CRP, IL-6), elevated or depressed endocrinological parameters (ACTH, cortisol, DHEA-S), and altered LAC levels emerge and are specific correlation profiles associated with the expression of diverse subgroup variables (see subquestion 2)?

Countries

Germany

Contacts

Public ContactMaximilian Niebler

Lehrstuhl für KJPP der Universität Regensburg

maximilian.niebler@stud.uni-regensburg.de+49 (0)941 941-4001

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026