Treatment Resistant Depression (TRD)
Conditions
Brief summary
Change score from baseline to week 6 in Montgomery-Asberg-Depression Rating Scale (MADRS)
Detailed description
Response, defined as 50% MADRS score reduction from baseline; Remission, defined as MADRS score <10, Changes in BDI-II from baseline to week 6, CGI-S, CGI-I, PGIC, and SOFAS will be determined, and EuroQol-5 with MCID as well as ASEX will also be collected, Change in glucose, glycosylated hemoglobin (HbA1c), total, HDL- and LDL-cholesterol, C-reactive protein (CRP), and interleukin-6 levels from baseline to week 6, Safety endpoints of AE, tolerability and acceptability
Interventions
Sponsors
Charite Universitaetsmedizin Berlin KöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change score from baseline to week 6 in Montgomery-Asberg-Depression Rating Scale (MADRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response, defined as 50% MADRS score reduction from baseline; Remission, defined as MADRS score <10, Changes in BDI-II from baseline to week 6, CGI-S, CGI-I, PGIC, and SOFAS will be determined, and EuroQol-5 with MCID as well as ASEX will also be collected, Change in glucose, glycosylated hemoglobin (HbA1c), total, HDL- and LDL-cholesterol, C-reactive protein (CRP), and interleukin-6 levels from baseline to week 6, Safety endpoints of AE, tolerability and acceptability | — |
Countries
Germany
Outcome results
None listed