Suicide is 2-7x higher in Veterans than non-veterans, and may be related to brain kynurenine
pathway (KP) dysregulation and NMDA receptor (NMDAR) hyperactivation. Experimental drug
"AV-101" modulates the brain KP, with possible downstream NMDAR deactivation. The
investigators will examine AV-101 NMDAR modulation by testing dose-response effects on
resting state EEG, Mismatch Negativity, and P50 gating. Twelve healthy Operation Enduring
Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans will be
administered single dose AV-101 720 mg, 1440 mg, and placebo over 3 weeks in a randomized,
double-blind, cross-over trial. Repeated measures General Linear Models will test
dose-response effects. Suicide prevention is an important Veterans Affair (VA) mission. This
study is a first step to testing anti-suicidal effects of AV-101 in Veterans.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Marijn Lijffijt, PhD
Collaborators:
Michael Debakey Veterans Affairs Medical Center Michael E. DeBakey VA Medical Center VistaGen Therapeutics, Inc.