F30-F39
Conditions
Interventions
Group 1: Patients do not receive the TSE (Therapeutic Sleep Deprivation) as part of the study, but as part of their therapy programme at the central institute. Patients who suffer from a depressive ep
Sponsors
Zentralinstitut für seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Presenting with an episode of major depression in the clinic
Exclusion criteria
Exclusion criteria: comorbid substance use disorder medication changes 1-5 Days before TSE session
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study, three main hypotheses will be tested: 1. the two extreme groups ("non-responders" versus "responders") differ in their respective gene expression profiles, epigenetics, proteome, microbiome, actimetry, psychometry, as well as functional level and mood. 2. the samples of the measurement timepoints (before TSE, after TSE and the two further follow-up times) differ in their gene expression profiles, epigenetics, microbiome, proteome, actimetry, psychometry, as well as the functional level and mood. 3) From the gene expression profiles, epigenetics, microbiome, proteome, actimetry, psychometry, as well as the functional level and mood, new, more reliable and valid predictors for a therapeutic response can be found. The primary endpoint is the Clinical Global Impression Scale for Global Improvement (CGIC) in the afternoon after TSE, values = 2 are considered response and values = 3 are considered treatment non-response. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is also measured with the CGIC 3 days after the TSE, 1 week after TSE and 3 weeks after TSE. | — |
Countries
Germany
Contacts
Public ContactLea Sirignano
Zentralinstitut für seelische Gesundheit
Outcome results
None listed