F32
Conditions
Interventions
Group 1: In this study arm, healthy participants without current or past psychiatric disorders are included. This arm serves as the control group. No therapeutic intervention is performed. Ceramide le
Sponsors
LVR-Universitätsklinik Essen
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patient group Diagnosis of a depressive episode (F32) or recurrent depressive disorder (F33) according to ICD-10. Patients may receive antidepressant medication, undergo electroconvulsive therapy (ECT), ketamine, or repetitive transcranial magnetic stimulation (rTMS), be in psychotherapeutic treatment, or not currently receive any specific treatment for depression. Age = 18 years. Sufficient understanding of the German language to participate in study procedures (in particular questionnaires and interviews). Capacity to provide informed consent and provision of written informed consent. In case of comorbid substance use disorder: documented abstinence for at least four weeks prior to study inclusion; tobacco use is not considered an exclusion criterion. Healthy control group Age = 18 years. No current or past history of depressive, psychotic, or substance use disorder. No current psychopharmacological or psychotherapeutic treatment. Sufficient understanding of the German language to participate in study procedures. Capacity to provide informed consent and provision of written informed consent.
Exclusion criteria
Exclusion criteria: Patient group Presence of another primary psychiatric disorder (e.g., schizophrenia, bipolar disorder) that predominates over the depressive symptoms. Acute substance-induced disorder or insufficient abstinence in case of substance use disorder (< 4 weeks), with the exception of tobacco use. Severe neurological disorders (e.g., neurodegenerative diseases, clinically relevant sequelae after stroke, epilepsy). Severe or unstable medical conditions (e.g., decompensated cardiac, hepatic, or renal disease). Acute infections or inflammatory conditions at the time of blood sampling. Use of medications with a potentially relevant influence on lipid metabolism or redox status, if discontinuation is not medically justifiable (e.g., high-dose corticosteroids). Pregnancy or breastfeeding. Lack of capacity to provide informed consent. Healthy control group Current or past history of any psychiatric disorder. Regular use of psychotropic medication. Presence of substance use disorder or insufficient abstinence (< 4 weeks), with the exception of tobacco use. Severe neurological disorders. Severe or unstable medical conditions. Acute infections or inflammatory conditions at the time of blood sampling. Use of medications affecting lipid metabolism or redox status (e.g., corticosteroids). Pregnancy or breastfeeding. Lack of capacity to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint The primary endpoint is the change (?) in ceramide concentration in peripheral blood (EDTA plasma) of patients with a depressive episode between baseline and predefined follow-up time points during treatment. Time points of assessment: Baseline (prior to initiation of treatment) Week 2 Week 4 (or after completion of a defined treatment cycle in ECT, ketamine, or rTMS) Healthy control subjects will undergo a single blood sampling for comparative analysis. Data acquisition and measurement methods: Peripheral venous blood samples will be collected in EDTA tubes and processed according to standardized protocols (centrifugation, aliquoting, and storage at -80 °C). Ceramide concentrations will be quantified using liquid chromatography–tandem mass spectrometry (LC-MS/MS). Data will be analyzed as intra-individual changes (? from baseline) and compared between patients and healthy controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical outcomes Change in depression severity assessed using: Hamilton Depression Rating Scale (HAM-D) Beck Depression Inventory-II (BDI-II) Assessed at baseline, week 2, and week 4 Correlation analysis between changes in ceramide levels and clinical improvement 2. Cellular origin of ceramide production Determination of ceramide concentrations in different blood compartments (e.g., plasma vs. peripheral blood cells) Optional: analysis in isolated immune cell populations (e.g., monocytes) Aim: to identify potential cellular sources contributing to therapy-associated changes in ceramide levels 3. Redox status Measurement of oxidized glutathione (GSSG) in peripheral blood Optional: calculation of the GSH/GSSG ratio as a marker of oxidative stress Assessment at baseline and follow-up time points Analysis of the association between ceramide levels and redox status 4. Treatment-specific effects (exploratory) Comparison of ceramide dynamics across different treatment modalities: Antidepressants Electroconvulsive therapy (ECT) Ketamine Repetitive transcranial magnetic stimulation (rTMS) 5. Temporal dynamics (exploratory) Longitudinal analysis of ceramide levels, redox parameters, and clinical outcomes Identification of early biomarkers predictive of treatment respons | — |
Countries
Germany
Contacts
Public ContactMaximilian Schiller
Universitätsklinikum Essen
Outcome results
None listed