ICD10 F32.2-3
Conditions
Interventions
Group 1: Patients with treatment-resistent MDD who are treated with esketamine are included in the study.
Two visits (T1 and T2) are carried out 4 weeks apart.
During the routine visits, the follow
Sponsors
Fraunhofer ITMP
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of MDD (treatment-resistant depression (TRD)) according to the label of intranasal esketamine (TRD is defined as an inadequate response to at least two courses of antidepressant medication of adequate dose and duration) • Current esketamine intake and start of esketamine intake within the last 4 weeks • DeFlame study enrolment • Age = 18 and = 55 years • Written informed consent obtained prior to the initiation of any study protocol-required procedures • General understanding of study procedure and informed consent • Capable of giving consent
Exclusion criteria
Exclusion criteria: • Severe somatic disease as judged by the treating physician • Contraindications for MRI (e.g., tattoo in neck/ head area, permanent makeup, dentures with magnetic fixation, metal/magnetic implants (Pacemaker, defibrillator, joint endoprosthesis, heart valve, stent, metal, plastics, silicone, vascular/surgical clips, vascular endoprosthesis, metal pins, skin chips, braces, dental implants, garnet/other metal splinters, coil/intrauterine device, acupuncture needles, insulin pump, analgesic pump, neurostimulator, hearing implant, intraport) • Contraindication for contrast medium (e.g., increased creatinine, liver transplant, kidney transplant, Gadovist allergy) • Current participation in an interventional clinical trial or within 30 days prior to study entry • Imprisoned or incapable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is developing an outcome prediction model from multi-modal data gathered in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Two visits are carried out within the routine care and data is documented and used for the study: T1 (first visit, shortly before or max. 24-72 hours after the start of esketamine therapy) and T2 (4 weeks after the start of esketamine therapy). The following secondary endpoints will be recorded and analysed: o Composition of the gut microbiome and its metabolites before and after esketamine treatment o Comparisons of peripheral inflammatory markers at visit 1 (T1) and visit 2 (T2) o Immune profile in patients with depression at T1 and T2 o Correlation of severity of depression (measured by MADRS) and immune profile o Comparison of the arousal measured by vigilance EEG at T1 and T2 o T1/T2 relaxation time, proton density, and water diffusivity at T1 and T2 o Correlation of the MRI, EEG, microbiome and blood parameters to severity of depression o MADRS score and change to T1 o SHAPS-D score and change to T1 o CTQ score at T1 o PSS-10 score and change to T1 o Stressful life events at T1 and T2 o IDS-30 interview and self-rated score and change to T1 o CSSR-S score at T1 and T2 o M.I.N.I. score at T1 o FFQ score at T1 and T2 o Proportion of patients with lack of effect (Lack of effect is defined as reduction of <50% in MADRS score) | — |
Countries
Germany
Contacts
Public ContactKatrin Donde
Fraunhofer ITMP
Outcome results
None listed