F32 F33 F31
Conditions
Interventions
Group 1: Pat (N=50) with TAU AND 8 week intervention
Group 2: Pat (N=50) with TAU
Group 3: HC (N=25) Baseline measurement
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change in immune biomarkers (hsCRP, IL-6 and IL-7) - Monocyte gene cluster 3 expression - Number of memory T cells 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
| Measure | Time frame |
|---|---|
| - Improvement mood disorder (HDRS-17 score) - VO2 max test: Fitness level within subjects and between groups at baseline and end. - Change in psychophysiological correlates measured by accelerometer - Change of cognitive markers | — |
Countries
Belgium, Germany, Netherlands
Contacts
Public ContactBernhard Baune
Universitätsklinikum MünsterKlinik für Psychische Gesundheit
Outcome results
None listed