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

Recruiting

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00030637
• Lead Sponsor: ehrstuhl für Kinder- und Jugendpsychiatrie und -psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg (medbo)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)?