ARTICLE | Clinical News

GLYX-13: Additional Phase IIb data

December 15, 2014 8:00 AM UTC

Additional data from 160 patients who responded to GLYX-13 during the 6-week stabilization period and were re-randomized in the double-blind, U.S. Phase IIb trial showed that IV GLYX-13 weekly missed the primary endpoint of improving clinical response, defined as a >50% reduction in HDRS-17 score from baseline, vs. placebo in the second 6-week randomized withdrawal period. The trial enrolled 386 patients with MDD who had an inadequate or partial response to their antidepressants to receive twice-weekly 5 mg/kg GLYX-13 or once-weekly 10 mg/kg GLYX-13 for 6 weeks in the stabilization period of the trial. If a patient achieved a response, then placebo was given until relapse. In the 6-week randomized withdrawal period, 160 patients who achieved a response during the stabilization period were randomized to receive either dose of GLYX-13 or placebo. ...