VistaGen Launches Phase 2 Study of AV-101 as Adjunct for Depression

VistaGen Therapeutics has initiated a phase 2 clinical trial to examine the safety and efficacy of its oral NMDA receptor antagonist AV-101 (L-4-chlorokynurenine) as an adjunctive therapy for patients with treatment-resistant depression.

As part of the ELEVATE trial, patients with depression who have failed to adequately respond to standard antidepressant therapy (including FDA-approved selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors) will be randomly assigned to receive either AV-101 or placebo once daily in conjunction with their ongoing antidepressant for 14 days.

The primary endpoint of the study is the change in depressive symptoms as measured by the Montgomery–Åsberg Depression Rating Scale. Maurizio Fava, M.D., of Massachusetts General Hospital and Harvard Medical School will be leading the ELEVATE trial, which includes study sites across the United States. The researchers hope to enroll about 180 patients. ■