Dehydroepiandrosterone (DHEA) as augmentation of standard antidepressants in treatment-resistant depression: a randomized controlled trial (DARE-Trial) - A multicenter, randomized, double-blind, placebo-controlled trial with group sequential design

Condition studied

Treatment Resistant Depression (TRD)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change score from baseline to week 6 in Montgomery-Asberg-Depression Rating Scale (MADRS)

Endpoint detail

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