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.
Conditions
Interventions
Trade Name: Mirtazapin-CT
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Mirtazapin
CAS Number: 61337-67-5
Current Sponsor code: PR2
Other descriptive name: Mirtazapin-CT
Concentration unit:
Sponsors
Rainer Rupprecht, Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): In this double-blind, placebo-controlled, parallel group study, 80 depressive patients will be randomly assigned to one of four tratment groups. This number seems necessary in order to attain a 60-Completer threshold, if we take into consideration the possible drop-out-rate. The 20 patients in each group receive either 10mg of Escitalopramn, 30mg of Mirtazapine, 25 mg of Agomelatine or a placebo-based treatment for at least seven days. The patients are administered the medicine as follows: Escitalopram at 08.00 hours, Mirtazapine or Agomelatine at 22.00 hours, in accordance with the usual clinical practice. For blinding purposes, the double-dummy-technique will be employed. In case of need, the patients in all treatment groups can be administered Lorazepam (up to 3mg/d), Zopiclon (up to 15mg/d) oder Zolpidem (up to 20mg/d). The following tables give an overview of the design of the study. The clinical trial period is planned to last two years. Day 1st: baseline laboratory screening stool and urine sample; Dex 1.5 mg; baseline rating 2nd: baseline Dex/CRH test 3rd: resting day 4th: baseline fMRI 5th: medication plasma levels, day 1 of treatment 6th: day 2 of treatment 7th: day 3 of treatment, rating 8th: day 4 of treatment, Dex 1.5 mg 9th: day 5 of treatment, Dex/CRH-test 10th: day 6 of treatment 11th: medication plasma levels, day 7 of treatment, stool probe, 2nd fMRI 11+: treatment according clinical requirement; stool probe after 8 weeks of treatment or at discharge Treatment protocol treatment group: 0 treatment: Placebo wash-out: 0 week 1, day 1: 0 week 2: treatment according clinical requirements week 3: treatment according clinical requirements week 4: treatment according clinical requirements week 8: continuation of antidepressant treatment and plasma level determinations according clinical requirements treatment group: 1 treatment: Escitalopram wash-out: 0 week 1, day 1: 10 mg/d week 2: 10mg/d week 3: | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): If no reduction of at least 20% in HAMD-21 scale is seen after 2 weeks of treatment, treatment according usual clinical requirements will be offered. Each patient will be advised independently of the study only according to clinical reasons. In case patients respond well to the treatment, it is considered to continue pharmacotherapy. In case of nonresponse other pharmacological and non-pharmacological interventions including augmentation strategies will be offered.;Timepoint(s) of evaluation of this end point: after 2 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactBKH Regensburg Psychiatrie
Universitätsklinikum Regensburg
Outcome results
None listed