F32 F33
Conditions
Interventions
Group 1: Naturalistic study on the course of depression symptoms under open antidepressant treatment of patients with major depression with the aim to validate genomic biomarkers for the prediction of
Sponsors
Max-Planck-Institut für Psychiatrie
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: Inpatients with a moderate or severe depressive episode (HAMD-21 = 14)
Exclusion criteria
Exclusion criteria: Pregnant or lactating women; drug or alcohol addiction; depressive episode secondary to a somatic/neurological disorders or to substance addiction; severe neurological or somatic comorbid condition potentially affecting the study outcome (e.g., dementia, Morbus Cushing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in depression severity after 8 weeks of antidepressant treatment (T8) as evaluated with the 21-item version of the Hamilton Rating Scale for Depression (HAM-D) with respect to depression severity at study entry (T0). Relative gene expression of ABCB1, FKBP5, P2RX4 and P2RX7 and DNA methylation in CpG-rich regions of these genes will be determined as genomic biomarkers from blood samples at T0 and after six weeks (T6) as predictors of the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission state after 8 weeks of antidepressant treatment (T8) as defined by a total score of the 21-item version of the Hamilton Rating Scale for Depression (HAM-D) of equal or less than 9. | — |
Countries
Germany
Contacts
Public ContactMarcus Ising
Max-Planck-Institut für Psychiatrie
Outcome results
None listed