Additional Relevant Details
The trial was a 3-week randomized, double-blind, placebo-controlled, sequential parallel comparison design (SPCD) study of intermittent doses of adjunctive CERC-301 (12 mg or 20 mg) or placebo in the treatment of subjects with MDD who have not adequately responded to antidepressant therapy, either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine uptake inhibitor (SNRI).The study randomized 115 subjects. The study was conducted in two sequential one week periods. Placebo non-responders in Period 1 were re-randomized to either study drug or placebo in Period 2. Subjects received treatment at the beginning of each period. The results of Periods 1 and 2 were averaged. The study included a one-week follow-up.In this SPCD designed study, the mean improvement from baseline on the Bech-6 scale averaged over Days 2 and 4 post treatment for Period 1 was 3.82 for placebo, 2.50 for the 12 mg dose and 4.11 for the 20 mg dose, and for Period 2 was 2.86 for placebo, 1.64 for the 12mg dose and 3.38 for the 20 mg dose. The weighted average for the difference in placebo and drug improvement (placebo minus drug) was +1.45 and -0.04 for 12 mg and 20 mg CERC-301, respectively.


In a pre-specified analysis of the mean improvement from baseline on the Bech-6 at Day 2 for Period 1 was 3.59 for placebo, 4.71 for 20 mg; and for Period 2, 2.30 for placebo and 3.52 for 20 mg. In another pre-specified analysis of the mean improvement from baseline on the HDRS-17 at Day 2 for Period 1 was 6.24 for placebo and 9.71 for 20 mg; and for Period 2, 3.60 for placebo and 5.38 for 20 mg.