MOODSTRATIFICATION IMMUNOSTRATAPremature immune ageing to predict the effect of physical training intervention, in mood disorders

Not Applicable

Recruiting

• Conditions: F32; F33; F31; Depressive episode; Recurrent depressive disorder; Bipolar affective disorder

• Registration Number: DRKS00022887
• Lead Sponsor: niversitätsklinikum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Inclusion criteria for patients with MDD:
- Depressive episode in the context of a unipolar or bipolar affective disorder
- HDRS-17 - value >13
- Age 18-65
- Preferably patients with antidepressant and/or mood-stabilising medication that does not have a sufficient effect
- Consent and IC

Inclusion criteria for healthy controls:
- No affective disorder in patient history
- Age 18-65
- Consent and IC

Exclusion Criteria

Exclusion criteria for MDD patients:
- Taking beta-blockers
- Anomalies in the ECG
- Permanent intake of anti-inflammatory drugs
- Existing or planned pregnancy or lactation
- Schizoaffective disorder, schizophrenia
- Increased risk of suicidal behaviour
- 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 immune system or mood (corticosteroids, anti-inflammatory medication, immunosuppressants)
- inability to complete the study programme
- Patients who are related to employees or have the same employment relationship

Exclusion criteria for healthy controls:
- Permanent use of anti-inflammatory medication
- Cancer in the last 5 years (except skin cancer or a precursor of cervical cancer)
- 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 immune system or mood (corticosteroids, anti-inflammatory medication, immunosuppressants)
- Existing or planned pregnancy or lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Change in immune biomarkers (hsCRP, IL-6 and IL-7)<br>- Monocyte gene cluster 3 expression<br>- Number of memory T cells<br><br><br><br>Blood samples are taken at the initial (week 1) and final examination (week 8). Among others, IL-7, hsCRP, IL-6 from serum are examined, gene signatures of monocytes on isolated monocytes are prepared from PBMCs by FACS analysis and gene signatures in whole blood samples are examined (by PAXGENE and Templus Blood RNA tube).

Secondary Outcome Measures

Name	Time	Method
- Improvement mood disorder (HDRS-17 score)<br>- VO2 max test: Fitness level within subjects and between groups at baseline and end.<br>- Change in psychophysiological correlates measured by accelerometer<br>- Change of cognitive markers