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

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ClinicalTrials.gov Identifier: NCT03078322
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : June 14, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : May 15, 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
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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03078322


Contacts
Contact: Ashley Sullivan 919-443-3403 VSGCL003@cato.com
Contact: Kathy Grako, PhD 858-251-4082 VSGCL003@cato.com

Locations
United States, California
VistaGen Investigational Site Recruiting
Garden Grove, California, United States, 92845
VistaGen Investigational Site Recruiting
National City, California, United States, 91950
United States, Florida
VistaGen Investigational Site Recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
VistaGen Investigational Site Recruiting
Atlanta, Georgia, United States, 30331
VistaGen Investigational Site Not yet recruiting
Augusta, Georgia, United States, 30912
United States, Louisiana
VistaGen Investigational Site Recruiting
Lake Charles, Louisiana, United States, 70629
United States, Maryland
VistaGen Investigational Site Recruiting
Gaithersburg, Maryland, United States, 20877
United States, New York
VistaGen Investigational Site Recruiting
New York, New York, United States, 10128
VistaGen Investigational Site Not yet recruiting
Rochester, New York, United States, 14618
United States, Ohio
VistaGen Investigational Site Recruiting
Dayton, Ohio, United States, 45417
United States, Pennsylvania
VistaGen Investigational Site Recruiting
Media, Pennsylvania, United States, 19063
United States, Rhode Island
VistaGen Investigational Site Recruiting
Lincoln, Rhode Island, United States, 02865
United States, Texas
VistaGen Investigational Site Recruiting
Houston, Texas, United States, 77030
VistaGen Investigational Site Recruiting
Houston, Texas, United States, 77058
United States, Washington
VistaGen Investigational Site Recruiting
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
VistaGen Therapeutics, Inc.

Responsible Party: VistaGen Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03078322     History of Changes
Other Study ID Numbers: VSG-CL 003
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs