Functional changes in the brain after application of antidepressants and their clinical impact, their relation to the stress hormone system and to the enterobacteria

Phase 1

• Conditions: Major Depressive Disorder is a chronic stress related disorder characterized by depressed mood and by vegetative and cognitive symptoms. Moreover, genetic, neuroendocrine and neurochemical biomarkers may predict impaired processing and regulation of emotions related to major depression as well as antidepressant treatment response in general. There is evidence, that the gut microbiome may influence stress, anxiety and depression-related behavior via effects on the host´s neuroendocrine system.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-003370-27-DE
• Lead Sponsor: Rainer Rupprecht, Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-24
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

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

Inclusion Criteria

•Male and female in-patients in the age between 18 and 65 years
•Major depressive disorder
•Admission on a voluntary basis independent of our study
•Written informed consent for trial participation after the scope and nature of the investigation have been explained to the patients before starting trial-related activities.
•Indication for antidepressant therapy independent of the clinical trial.
•primary unipolar depression (ICD-10: F32, F33) or bipolar depression (ICD-10: F31.3-5), current episode of depressed state for at least 2 weeks prior to baseline
•Physically healthy
•Right handedness (assessed by the Edinburgh Handedness Inventory (Oldfield, 1971))

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Schizophrenia, substance dependence as define by ICD-10 or any other psychiatric primary diagnosis (according to the ICD-10 criteria)
•major somatic or neurological disorder
•abnormalities in the laboratory screening at baseline (e.g. hypo- or hyperthyroid state, elevated liver enzymes, blood cell dyscrasias)
•lacking ability to give informed consent
•have been admitted to the clinic involuntarily during their present episode
•pregnancy or breast-feeding
•in case of the inclusion of premenomausal female patients insufficient contraception leads to exclusion from the study
•contraindications to magnetic resonance imaging patient with heart pacemaker or implanted metal in the scull
•or concurrent medication, which could alter emotional processing
•known history of alcohol or drug abuse during 6 month prior to the screening
•being at clinically risk of suicidal behavior (HAM-D Item 3 > 2 or clinical impression)
•involuntary admission to the hospital
•known allergies or hypersensitivity reactions or other contraindications for escitalopram, agomelatin or mirtazapine
•being treated with psychotropic medication < 3weeks before study (5weeks in case of fluoxetine pretreatment)
•Unusual diets leading to malnutrition
•Pretreatment with antibiotics or corticosteriods

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified