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.
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