NIMH Clinical Study

NIMH AV-101 Phase 2 Monotherapy Study for MDD

The U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH), is currently evaluating AV-101 in a Phase 2 monotherapy study for the treatment of MDD. This study is being conducted and funded by the Dr. Carlos Zarate of the NIMH. AV-101 has a novel mechanism of action (MOA), meaning its MOA is fundamentally different from all current FDA-approved treatments for depression, with potential to further drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. VistaGen's development strategy for AV-101 is focused on establishing it as the primary augmentation option for patients with MDD having an inadequate response to current, FDA-approved antidepressants, displacing adjunctive use of atypical antipsychotics such as aripiprazole in the current depression treatment paradigm.

Study Center and Contact

Site Contact Principal Investigator
National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD 20892
United States
Libby Jolkovsky
(877) 646-3644

Carlos A Zarate, M.D.

For more information about the study, please visit