F32 F33
Conditions
Interventions
Group 1: Intervention: The study is looking for patients currently on a depressive episode and do not respond adequately to the drug therapy. The study will be carried out in total 6 months (24 weeks)
Sponsors
Klinik für Psychiatrie und Psychotherapie II der Universität Ulm
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in immune biomarkers (hsCRP, IL-6 and IL-7) • Expression of monocyte gene clusters 3 • Number of storage T cells 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
| Measure | Time frame |
|---|---|
| Improvement in symptom severity (HDRS-17 score) • Change in the psychophysiological correlates, measured using a fitness bracelet: including movement data, number of steps, sleep quality • Change in cognitive markers | — |
Countries
Belgium, Germany, Netherlands
Contacts
Public ContactPaulo Kling Lourenco
Klinik für Psychiatrie und Psychotherapie II der Universität Ulm
Outcome results
None listed