drugset / Trial / NCT02459236

A Study of Intermittent Doses of CERC-301 in MDD

NCT02459236

Phase 2 Completed 115 enrolled Avalo Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

There is a significant unmet medical need for rapidly acting treatment of subjects with severe major depressive disorder (MDD) who have not adequately responded to antidepressant therapy. Alternative therapies require weeks to achieve full efficacy, may have significant side effects, and still fail in a high percentage of subjects. Rapid reduction of severe depression by pharmacological therapy is important to reduce the need for hospitalization and risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable, N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it provides rapid onset of antidepressant effects and an effect size similar to that seen with experimental intravenous NMDA modulators.

Timeline

Start
2015-06
Primary completion
2016-09
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject RISLENEMDAZ Small molecule 12 mg
Subject RISLENEMDAZ Small molecule 20 mg