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CERC-301 fails to meet efficacy endpoint for treatment-resistant MDD
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Phase 2 study findings from Cerecor indicated CERC-301, an oral, N-methyl D-aspartate receptor subtype 2B selective antagonist, was not significantly effective as an adjunctive treatment for treatment-resistant major depressive disorder.
“While the trial failed to achieve the primary efficacy endpoint, we note that these results suggest a potentially clinically meaningful treatment effect in the 20 mg dose at day 2,” Ronald Marcus, MD, chief medical officer at Cerecor, said in a press release.
To assess efficacy of CERC-301 as an adjunctive treatment for MDD, researchers conducted a 3-week randomized, double-blind, placebo-controlled, sequential parallel comparison design study among 115 individuals with MDD who did not adequately respond to antidepressant therapy. Study participants received 12 mg or 20 mg of CERC-301 or placebo.
From baseline to day 2 and 4 of post-treatment, mean improvement in Bech-6 scale scores were 3.82 for the placebo group, 2.5 for those who received 12 mg of CERC-301 and 4.11 for those who received 20 mg of CERC-301, according to findings from the sequential parallel comparison study.
Pre-specified analysis indicated mean improvement in Bech-6 scores of 3.59 for the placebo group and 4.71 for the 20-mg group after the first week of treatment and 2.3 for the placebo group and 3.52 for the 20-mg group for the second week.
Mean improvement from baseline in Hamilton Depression Scale (HDRS-17) scores was 6.24 for the placebo group and 9.71 for the 20-mg group in week 1 and 3.6 for the placebo group and 5.38 for the 20-mg group for week 2.
Researchers did not find significant improvement in any other secondary endpoints.
“From a clinician’s perspective, these data warrant additional clinical testing to fully explore the potential for this compound to treat MDD,” Maurizio Fava, MD, of Massachusetts General Hospital, said in the release. “I would note that a minimum of 2 points of improvement on the HDRS-17 scale compared to placebo is considered by many, and noted in MDD studies, to be clinically meaningful.”