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

ID

22

DZPG Site

Mannheim/Heidelberg/Ulm
General Information
Status

Ongoing (II): Recruitment and data collection ongoing

Description

MitO2Health aims to develop and empirically prove a radically new pathophysiological model of Major Depressive Disorder (MDD) as a systemic energy deficiency disease. Traditionally, MDD is conceptualized as a neurotransmitter deficiency in the brain. However, with pioneering methods my group has provided evi-dence for reduced mitochondrial energy production in MDD, characterizing it as a cellular-metabolic disorder with a lowered production of adenosine triphosphate (ATP). Reduced mitochondrial bioenergy production and impairments in oxygen (O2) homeostasis (reduced levels of erythrocytes, less hemoglobin and its lower O2-binding affinity due to oxidative stress), as well as oxidative stress and inflammation (the "MitO2Health parameters") were consistently associated with an increased risk for MDD, but have been neglected so far in MDD research and therapy. In MitO2Health we will more comprehensively than ever before investigate the physiological mechanisms underlying MDD and will provide first longitudinal evidence on the mutual in-terplay between the MitO2Health parameters and MDD. Moreover, we will apply cognitive-behavioral therapy (CBT) as randomized treatment condition to test whether CBT-related MDD symptom reduction is coupled to a normalization of the MitO2Health parameters. We will treat 100 MDD patients with 6 months of CBT and compare them to 100 MDD patients of a waiting-list group and 100 healthy controls. Clinical and biological status will be assessed at four points over 18 months. We will thus characterize the biomarker pro-files of MDD treatment response and resistance as well as MDD symptom recurrence during a follow-up pe-riod. MitO2Health will not only establish a modern etiological model of MDD, but also identify biomarkers of individual therapy response and relapse. This will lead to new diagnostic standards and inspire personalized MDD treatment concepts that will fundamentally improve clinical outcomes in psychotherapy and psychiatry.

Paper

Not available.

Trial Number

DRKS00025457

Contact
PI

Prof. Dr. Iris-Tatjana Kolassa

Further PIs

None.

Survey Results
Is it an interventional or non-interventional study?
  • Interventional
Specification of study type
  • Other
Which other study type?

3 groups, 2 intervention groups with depressed patients, one healthy control group. One depressed group waits and the other receives psychotherapy. After the waiting period the this group also receives therapy

Is it a single or multi country study?

Single

Which country?

Germany

Who are participants?
  • Patients with specific diseases
Which diseases? (ICD-11 classification)
  • Mental, behavioural or neurodevelopmental disorders (06)
Mental, behavioural or neurodevelopmental disorders (ICD-11 classification)
  • Mood disorders
Recruitment setting
  • General population
  • Outpatient
Target sample size

300

Obtained sample size

100

Start of recruitment

2022

Minimum age of participants

18

Data sources for the study
  • Biological samples
  • Cognitive measurements
  • Questionnaire
  • Omics technology
Is it planned to share the data?

Undecided, it is not yet known if data will be made available

Additional information about data sharing

Needs always to be clarified with respect to patient consent in data sharing.

Are further follow-ups planned?

No

Is there consent to re-contact participants?

No

Is the implementation of further study components possible?

No

View raw data