AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
(ELEVATE Trial)
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: VistaGen Therapeutics, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The study will evaluate the safety and efficacy of AV-101.
Eligibility Criteria
Inclusion Criteria
Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least 8 weeks in duration.
Has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode.
Meet the threshold on the total HAMD-17 score of > 20
See 3 more
Treatment Details
Interventions
- AV-101 (NMDA Receptor Antagonist)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AV-101Experimental Treatment1 Intervention
L-4-chlorokynurenine 1440 mg daily for 14 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VistaGen Investigational SiteAugusta, GA
VistaGen Investigational SiteSaint Louis, MO
VistaGen Investigational SiteDayton, OH
VistaGen Investigational SiteMedia, PA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
VistaGen Therapeutics, Inc.Lead Sponsor