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Cerecor completes enrollment in mid-stage study of MDD candidate CERC-301

|About: Cerecor Inc. (CERC)|By: , SA News Editor

Cerecor (CERC) hits its enrollment target in a Phase 2 clinical trial, Clin301-203, evaluating CERC-301 for the adjunctive treatment of major depressive disorder (MDD), a Fast Track-designated indication by the FDA. Top-line data should be available in November.

The double-blind, placebo-controlled study has enrolled 115 subjects with MDD who experienced a severe depressive episode despite stable ongoing treatment with either a serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor. Participants have been randomized to receive intermittent 12 mg or 20 mg oral doses of CERC-301 or placebo seven days apart followed by a 14-day observation period. The primary endpoint is the change from baseline in depression as measured by a scale called Bech-6. Secondary endpoints also assess the change in depression from baseline as determined by a range of scales.

CERC-301, licensed from Merck (MRK +0.4%), is an N-methyl-D-aspartate receptor (NMDA) antagonist, a class of drugs that induce dissociative anesthesia (e.g., ketamine).

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