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

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)

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: AV-101; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • 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
      • VistaGen Investigational Site
  • Florida
    • Fort Myers, Florida, United States, 33912
      • VistaGen Investigational Site
    • Jacksonville, Florida, United States, 32256
      • VistaGen Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • VistaGen Investigational Site
    • Augusta, Georgia, United States, 30912
      • VistaGen Investigational Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • VistaGen Investigational Site
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • VistaGen Investigational Site
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • VistaGen Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • VistaGen Investigational Site
  • New York
    • New York, New York, United States, 10128
      • VistaGen Investigational Site
    • Rochester, New York, United States, 14618
      • VistaGen Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 45417
      • VistaGen Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • VistaGen Investigational Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • VistaGen Investigational Site
  • Texas
    • Houston, Texas, United States, 77030
      • VistaGen Investigational Site
    • Houston, Texas, United States, 77058
      • VistaGen Investigational Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • VistaGen Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
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 Names: L-4-chlorokynurenine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)	Depression questionnaire	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course of improvement including response rates	50% improvement on MADRS-10	2 weeks
Safety and tolerability will be assessed by incidence of adverse events (AEs)	Also include EKG, labs etc.	2 weeks

Collaborators and Investigators

• Sponsor: VistaGen Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (ACTUAL): March 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: VSG-CL 003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No