Modulation of the mineralocorticoid receptor as add-on treatment in XXXX : a randomized, double-blind, placebo-controlled proof-of-concept study.

@entity1 @entity308 @entity837 @entity701 @entity7842 @entity1482
Preclinical and clinical studies have suggested a role of the mineralocorticoid receptor (MR) in the response to antidepressants. We tested in a proof-of-concept study whether adding @entity7842 (an MR agonist) or @entity1482 (an MR antagonist) accelerates onset of action and improves efficacy of @entity837 in @entity1 with @entity308 . We included 64 in- and outpatients with @entity308 (Hamilton Depression Scale-17 score>18) in a double-blind, randomized, placebo-controlled trial. @entity1 were randomized in a 2:2:1 fashion to @entity7842 (0.2 mg/d, n=24) or @entity1482 (100 mg/d, n=27) or placebo (n=13) for the first 3 weeks during a 5-week treatment with @entity837 . No differences in mean HAMD change scores and in time to response emerged between treatments. However, among the responders, @entity1 treated with @entity7842 responded faster (Breslow test, p=0.05). The mean number of days to response was 16.0+/-2.6 days vs. placebo 22.2+/-2.0 vs. @entity1482 22.6+/-2.3 (F=3.78, p=0.03). In the whole group, plasma @entity701 increased during @entity1482 and decreased during @entity7842 treatment (F=2.4, p=0.04). In @entity1 treated with @entity7842 , non-responders had elevated @entity701 values compared to responders throughout the study period (F=5.1, p=0.04). Stimulation of MR with @entity7842 as adjunct to @entity837 accelerated the response in the group of responders while no effect emerged in the sample as a whole. A larger randomized controlled trial is warranted.
