Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03078322
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : October 9, 2019
Information provided by (Responsible Party):
VistaGen Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: AV-101 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: AV-101
L-4-chlorokynurenine 1440 mg daily for 14 days
Drug: AV-101
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Name: L-4-chlorokynurenine

Placebo Comparator: Placebo
Drug: Placebo
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Primary Outcome Measures :
  1. Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10) [ Time Frame: 2 weeks ]
    Depression questionnaire

Secondary Outcome Measures :
  1. Time course of improvement including response rates [ Time Frame: 2 weeks ]
    50% improvement on MADRS-10

  2. Safety and tolerability will be assessed by incidence of adverse events (AEs) [ Time Frame: 2 weeks ]
    Also include EKG, labs etc.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • If female, a status of nonchildbearing potential or use of an acceptable form of birth control.
  • Body mass index between 18 to 40 kg/m2.
  • Other criteria may apply

Exclusion Criteria:

  • History of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
  • Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within 6 months prior to screening.
  • Women who are pregnant or breastfeeding or a positive pregnancy test at screening or baseline.
  • Currently taking a prohibited adjunct therapy. Such drugs must be washed out for at least 4 weeks prior to baseline.
  • Current diagnosis of moderate or severe substance use (including alcohol) disorder (abuse or dependence, as defined by DSM-5), with the exception of nicotine dependence, at screening or within 6 months prior to screening.
  • In the opinion of the investigator, the subject has a significant risk for suicidal behavior
  • Has received electroconvulsive therapy, or had repetitive transcranial magnetic stimulation in the current episode.
  • Has received vagus nerve stimulation at any time prior to screening.
  • Any current or past history of any physical condition, which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03078322

Layout table for location information
United States, California
VistaGen Investigational Site
Garden Grove, California, United States, 92845
VistaGen Investigational Site
Los Angeles, California, United States, 90024
VistaGen Investigational Site
National City, California, United States, 91950
VistaGen Investigational Site
Oakland, California, United States, 94607
VistaGen Investigational Site
San Diego, California, United States, 92103
VistaGen Investigational Site
Temecula, California, United States, 92591
United States, Florida
VistaGen Investigational Site
Fort Myers, Florida, United States, 33912
VistaGen Investigational Site
Jacksonville, Florida, United States, 32256
United States, Georgia
VistaGen Investigational Site
Atlanta, Georgia, United States, 30331
VistaGen Investigational Site
Augusta, Georgia, United States, 30912
United States, Illinois
VistaGen Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Louisiana
VistaGen Investigational Site
Lake Charles, Louisiana, United States, 70629
United States, Maryland
VistaGen Investigational Site
Gaithersburg, Maryland, United States, 20877
United States, Missouri
VistaGen Investigational Site
Saint Louis, Missouri, United States, 63141
United States, New York
VistaGen Investigational Site
New York, New York, United States, 10128
VistaGen Investigational Site
Rochester, New York, United States, 14618
United States, Ohio
VistaGen Investigational Site
Dayton, Ohio, United States, 45417
United States, Oklahoma
VistaGen Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
VistaGen Investigational Site
Media, Pennsylvania, United States, 19063
United States, Texas
VistaGen Investigational Site
Houston, Texas, United States, 77030
VistaGen Investigational Site
Houston, Texas, United States, 77058
United States, Washington
VistaGen Investigational Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
VistaGen Therapeutics, Inc.
Layout table for additonal information
Responsible Party: VistaGen Therapeutics, Inc. Identifier: NCT03078322    
Other Study ID Numbers: VSG-CL 003
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms