Baylor/U.S. Department of Veterans Affairs Study

First-step clinical study focused on U.S. Veterans and Suicidal Ideation

A total of 12 healthy volunteer U.S. 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 clinical study to focus on target engagement and define a dose-response relationship between AV-101 and relevant biomarkers related to NMDA function possibly related to suicidal ideation (suicidal thoughts and behaviors). This first-step study in healthy volunteer U.S. Veterans is intended to facilitate progress towards a Phase 2 study involving AV-101 and U.S. Veterans who are battling suicidal ideation.

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 is being provided for substantially all other study-related 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/.