MOODSTRATIFICATION-IMMUNOSTRATA: Physical training intervention, premature immune aging and major mood disorders

Not Applicable

Recruiting

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

• Registration Number: DRKS00024952
• Lead Sponsor: Klinik für Psychiatrie und Psychotherapie II der Universität Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria for patients with MDD:
- Depressive episode in a unipolar or bipolar affective disorder
- HDRS-17 - value> 13
- Age 18-65
- Thoughts of the patient with an antidepressant and / or mood-stabilizing medication that does not work reliably
- Ability to give consent and IC

Exclusion Criteria

Taking beta blockers
- Anomalies in the EKG
- Long-term use of anti-inflammatory drugs
- Existing or planned pregnancy or breastfeeding
- Schizoaffective disorder, schizophrenia
- Increased risk of suicidal behavior
- Chronic uncontrolled systemic or metabolic disease (e.g. diabetes mellitus)
- Other significant chronic, uncontrolled somatic, organic, neurological diseases that affect mood
- Current or past (last four weeks) somatic medication that affects the immune system or mood (corticosteroids, anti-inflammatory medication, immunosuppressants)
- Inability to complete the study program
- Patients who are related to employees or who have the same employment relationship

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in immune biomarkers (hsCRP, IL-6 and IL-7)<br>• Expression of monocyte gene clusters 3<br>• Number of storage T cells<br><br>Blood will be taken during the initial (week 1) and final examinations (week 8). Among other things, IL-7, hsCRP, IL-6 from serum are examined, gene signatures of monocytes on isolated monocytes are produced using FACS analyzes from PBMCs and gene signatures are examined in whole blood samples (by PAXGENE and Templus Blood RNA tube).

Secondary Outcome Measures

Name	Time	Method
Improvement in symptom severity (HDRS-17 score)<br>• Change in the psychophysiological correlates, measured using a fitness bracelet: including movement data, number of steps, sleep quality<br>• Change in cognitive markers