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Major depression as a metabolic disorder: The role of oxygen homeostasis and mitochondrial bioenergetics in depression etiology and therapy

Major depression as a metabolic disorder: The role of oxygen homeostasis and mitochondrial bioenergetics in depression etiology and therapy - MitO2Health

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025457
Enrollment
300
Registered
2021-07-06
Start date
2021-12-03
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: Depressed group: Patients with major depressive disorder (MDD). This group will be immediately treated with 24 sessions of cognitive behavioral therapy. Blood samples, questionnaire data, and

Sponsors

Department of Clinical and Biological Psychology, Ulm University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: A diagnosis of major depressive disorder according to DSM-5; accepted psychological comorbidities: anxiety disorders, and somatoform disorders. Stable medication is permitted.

Exclusion criteria

Exclusion criteria: High suicidality, PTSD and complex PTSD, Borderline personality disorder, eating disorders, obsessive compulsive disorder, bipolar disorder, schizophrenia or a history of psychotic disorders, acute substance-related disorder, organic mental disorder, pregnancy and nursing, neurological diseases, immunological and endocrine disorders, autoimmune diseases such as chronic viral infections, rheumatoid arthritis, cardiovascular comorbidities, cancer, chronic obstructive pulmonary diseases, Body Mass Index (BMI) > 30, usage of certain intrauterine devices (eg. Mirena)

Design outcomes

Secondary

MeasureTime frame
Secondary outcomes will be measured using the whole blood and immune cells of the participants at the beginning of each time point. Oxygen-homeostasis-related parameters will be determined either from whole blood with a blood gas analyzer (glucose, lactate, pH, O2 and CO2 partial pressure), or from serum by clinical routine measurements (free iron, iron proteins, bilirubin), or with pulse oximeter (O2 saturation) and ear thermometer (body temperature). Inflammation parameters (CRP, IL-1beta, IL-2, IL-6, IL-10, TNF-alpha) will be determined from serum via enzyme-linked immunosorbent assay. Oxidative stress parameters will be determined from whole blood via Electron Spin Resonance (Reactive Oxygen Species) and indirectly from serum via enzyme-linked immunosorbent assay (8OH-dG, 8-isoprostane).

Primary

MeasureTime frame
Primary outcomes will be measured using the whole blood and immune cells of the participants at the beginning of each time point. ATP-turnover-related respiration, uncoupled respiration, and routine respiration will be measured from the immune cells, using high resolution respirometry. Mitochondrial density of the immune cells will be determined spectrophotometrically by measuring citrate syntase activity of the immune cells. Hemoglobin concentration and erythrocyte cell number per ml will be measured in whole blood.

Countries

Germany

Contacts

Public ContactRezan Nehir Mavioglu

Department of Clinical and Biological Psychology, Ulm University

nehir.mavioglu@uni-ulm.de+497315026596

Outcome results

None listed

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