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2210 – A Phase Ii Randomized, Double-blind, Placebo-controlled Trial Of Glyx-13 For The Rapid Treatment Of Major Depressive Disorder Using Central Ratings

Published online by Cambridge University Press:  15 April 2020

D. Popp ,
R. Burch ,
J.B.W. Williams ,
L.M. Price  and
M.J. Detke
D. Popp
Affiliation:
MedAvante, Inc., Hamiton, NJ, USA
R. Burch
Affiliation:
Naurex, Inc., Evanston, IL, USA
J.B.W. Williams
Affiliation:
MedAvante, Inc., Hamiton, NJ, USA Department of Psychiatry, Columbia University, New York, NY, USA
L.M. Price
Affiliation:
MedAvante, Inc., Hamiton, NJ, USA
M.J. Detke
Affiliation:
MedAvante, Inc., Hamiton, NJ, USA Department of Psychiatry, Indiana University, Indianapolis, IN, USA

Abstract

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Introduction

NMDA receptor ligands have been shown to rapidly treat depression but are associated with psychotomimetic effects. GLYX-13 is an NMDA receptor glycine site functional partial agonist with ~ 25% of the agonist activity of glycine or Dserine. Animal models suggest a single intravenous dose may produce long-term efficacy without psychotomimetic effects.

Objective

A phase II randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy of GLYX-13 with central raters.

Aim

To examine the effects of a single dose of GLYX-13 in subjects with inadequate response to previous treatment for MDD.

Methods

48 male and 68 female subjects received a single dose of GLYX-13 (1-/5-/10-/30-mg/kg) or placebo. Central raters assessed subjects via telephone using the HDRS-17 at Screening, Baseline, Days 1, 3, 7, 14, 21 and 28.

Results

The a priori primary efficacy ANCOVA on pooled drug dose versus placebo was not significant for change from baseline to Day 1 on HDRS-17 total score. MMRM revealed a statistically significant reduction in HDRS-17 total score versus placebo at Day 3 for 5-mg/kg (−4.4; p < .05) and a trend at Day 1 for 5-mg/kg (−3.5; p = .068) and at Day 7 for 5 and 10-mg/kg (−4.0 for both; p's = .059 and .073). GLYX-13 did not cause psychotomimetic side effects at any dose studied.

Conclusion

This study suggests that GLYX-13, an NMDA receptor glycine site functional partial agonist, rapidly reduces depression scores without eliciting psychotomimetic effects at therapeutic doses as assessed by central raters. Further study is indicated.

Type
Abstract
Information
European Psychiatry , Volume 28 , Issue S1: Abstracts of the 21th European Congress of Psychiatry , 2013 , 28-E1371
Copyright
Copyright © European Psychiatric Association 2012
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