Baylor/U.S. Department of Veterans Affairs Study
Electrophysiological Biomarkers of AV-101 in Healthy Volunteer Veterans
A total of 12 healthy volunteer Veterans from either Operation Enduring Freedom, Operation Iraqi Freedom or Operation New Dawn will be administered single doses of AV-101, at 720 mg and 1440 mg, and placebo, over three weeks in a randomized, double-blind, cross-over study to define a dose-response relationship between AV-101 and relevant biomarkers related to NMDA function and others possibly related to suicidality. The results of this first-step study in healthy volunteer Veterans could lead to a Phase 2 study involving AV-101 and Veterans who are battling suicidal ideation or behaviors.
VistaGen and the U.S. Department of Veterans Affairs (VA) entered into a Material Transfer Cooperative Research and Development Agreement (MT CRADA) regarding clinical trial material for this study, and government funding from the VA will be provided for substantially all other study costs.
For more information about the study, please visit www.clinicaltrials.gov.
Support Resources for Veterans and their Families
Veterans who are in crisis or having thoughts of suicide, and those who know a Veteran in crisis, should call the Veterans Crisis Line for confidential support 24 hours a day, seven days a week, 365 days a year at 800-273-8255 and press 1, chat online at VeteransCrisisLine.net/Chat or send a text message to 838255.
To reach the National Suicide Prevention Lifeline network, please call 1-800-273-8255 (available 24 hours every day). Learn more about VA’s suicide-prevention resources and programs at www.mentalhealth.va.gov/suicide_prevention/.