VistaGen Therapeutics has partnered with the US Baylor College of Medicine (Baylor) to carry out an interventional clinical trial of AV-101 as a potential treatment for suicidal veterans.
The randomised, placebo-controlled, double-blind cross-over trial is expected to enrol altogether 12 healthy veterans from either Operation Enduring Freedom, Operation Iraqi Freedom or Operation New Dawn.
During the trial, the subjects will receive single doses of AV-101 at 720mg and 1,440mg, as well as placebo, over a period of three weeks.
The trial aims to define a dose-response relationship between AV-101 and relevant biomarkers associated with N-methyl-D-aspartate (NMDA) function and others possibly related to suicidality, as well as safety and tolerability.
The trial’s principal investigator Dr Marijn Lijffijt said: “The suicide rate is two times higher in Veterans than in citizens of equivalent age and gender. A priority for suicide prevention is to come up with novel treatment targets for safe and rapidly acting interventions to impact acute suicidality, which is not adequately addressed with current treatments.
“This study is the first step in working to revolutionise the way that we treat suicidal ideation and behaviours. Our expectation is to complete the dosing by the end of September 2018, with top-line results from the study expected by the year end.
“The results of this initial study in healthy volunteer Veterans could lead to a Phase ll study involving AV-101 and Veterans who are battling suicidal ideation or behaviours.”
AV-101 is currently being studied in two separate Phase lll clinical studies for the treatment of major depressive disorder.