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Completed Phase 2 Interventional

AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression

ClinicalTrials.gov ID: NCT03078322

Public ClinicalTrials.gov record NCT03078322. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 9:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Double-Blind, Placebo-Controlled, Phase 2 Trial to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) as Adjunct to Current Antidepressant Therapy in Patients With Major Depressive Disorder (the ELEVATE Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study will evaluate the safety and efficacy of AV-101.

Study identification

NCT ID
NCT03078322
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
VistaGen Therapeutics, Inc.
Industry
Enrollment
180 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 5, 2018 (Actual)
Primary completion
Oct 1, 2019 (Actual)
Completion
Oct 1, 2019 (Actual)
Last update posted
Oct 9, 2019

2018 – 2019

United States locations

U.S. sites
22
U.S. states
13
U.S. cities
21
Facility City State ZIP Site status
VistaGen Investigational Site Garden Grove California 92845 —
VistaGen Investigational Site Los Angeles California 90024 —
VistaGen Investigational Site National City California 91950 —
VistaGen Investigational Site Oakland California 94607 —
VistaGen Investigational Site San Diego California 92103 —
VistaGen Investigational Site Temecula California 92591 —
VistaGen Investigational Site Fort Myers Florida 33912 —
VistaGen Investigational Site Jacksonville Florida 32256 —
VistaGen Investigational Site Atlanta Georgia 30331 —
VistaGen Investigational Site Augusta Georgia 30912 —
VistaGen Investigational Site Hoffman Estates Illinois 60169 —
VistaGen Investigational Site Lake Charles Louisiana 70629 —
VistaGen Investigational Site Gaithersburg Maryland 20877 —
VistaGen Investigational Site St Louis Missouri 63141 —
VistaGen Investigational Site New York New York 10128 —
VistaGen Investigational Site Rochester New York 14618 —
VistaGen Investigational Site Dayton Ohio 45417 —
VistaGen Investigational Site Oklahoma City Oklahoma 73112 —
VistaGen Investigational Site Media Pennsylvania 19063 —
VistaGen Investigational Site Houston Texas 77030 —
VistaGen Investigational Site Houston Texas 77058 —
VistaGen Investigational Site Bellevue Washington 98007 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03078322, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 9, 2019 · Synced Oct 18, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03078322 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →