Suicidal Ideation (SI)

According to the World Health Organization, every year approximately 800,000 people worldwide take their own life and many more attempt suicide.1 The U.S. Centers for Disease Control views suicide as a major public health concern in the U.S. as rates of suicide have been increasing for both men and women and across all age groups.2 Suicide is the 10th leading cause of death in the U.S. and is one of just three leading causes that are on the rise.3 According to experts in the field of suicidal ideation (SI), characterized as suicidal thoughts and behavior, the number of Americans who die by suicide is, since 2010, higher than those who die in motor vehicle accidents. People of all genders, ages, and ethnicities can be at risk for suicide. Suicidal ideation is complex and there is no single cause. The National Institute of Mental Health attributes many different factors to someone making a suicide attempt, including, but not limited to, depression, other mental health disorders or substance abuse. Additionally, according to reports released by the U.S. Department of Veterans Affairs (VA), the U.S. Military Veteran population is at significantly higher risk for suicide than the general population.

We collaborated with Baylor College of Medicine (Baylor) and the VA on a Phase 1b target engagement study of AV-101 in healthy volunteer U.S. Military Veterans from Operation Enduring Freedom, Operation Iraqi Freedom or Operation New Dawn (the Baylor Study). In the double-blind, randomized, cross-over controlled trial, 10 healthy volunteer Veterans received single doses of AV-101 (720 mg and 1440 mg) and placebo. The primary goal of the study was to identify and define a dose-response relationship between AV-101 and multiple electrophysiological (EEG) biomarkers related to NMDAR function, as well as blood biomarkers associated with suicidality. The findings suggest that, in healthy Veterans, the higher dose of AV-101 (1440 mg) was associated with dose-related increase in the 40 Hz Auditory Steady State Response (ASSR), a robust measure of the integrity of inhibitory interneuron synchronization.

Both doses of AV-101 were well-tolerated, and there were no dissociative adverse events or serious adverse events.

Dr. Marijn Lijffijt, assistant professor of psychiatry research at Baylor and the Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston served as Principal Investigator of the study. 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 VA funding was provided for all other study costs.

  1. World Health Organization, https://www.who.int/en/news-room/fact-sheets/detail/suicide
  2. U.S. Centers for Disease Control, https://www.cdc.gov/vitalsigns/pdf/vs-0618-suicide-H.pdf
  3. U.S. Centers for Disease Control, https://www.cdc.gov/media/releases/2018/p0607-suicide-prevention.html