AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
NCT ID: NCT03078322
Last Updated: 2019-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2018-03-05
2019-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AV-101
L-4-chlorokynurenine 1440 mg daily for 14 days
AV-101
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Placebo
Placebo
Placebo
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Interventions
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AV-101
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Placebo
Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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VistaGen Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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VistaGen Investigational Site
Garden Grove, California, United States
VistaGen Investigational Site
Los Angeles, California, United States
VistaGen Investigational Site
National City, California, United States
VistaGen Investigational Site
Oakland, California, United States
VistaGen Investigational Site
San Diego, California, United States
VistaGen Investigational Site
Temecula, California, United States
VistaGen Investigational Site
Fort Myers, Florida, United States
VistaGen Investigational Site
Jacksonville, Florida, United States
VistaGen Investigational Site
Atlanta, Georgia, United States
VistaGen Investigational Site
Augusta, Georgia, United States
VistaGen Investigational Site
Hoffman Estates, Illinois, United States
VistaGen Investigational Site
Lake Charles, Louisiana, United States
VistaGen Investigational Site
Gaithersburg, Maryland, United States
VistaGen Investigational Site
St Louis, Missouri, United States
VistaGen Investigational Site
New York, New York, United States
VistaGen Investigational Site
Rochester, New York, United States
VistaGen Investigational Site
Dayton, Ohio, United States
VistaGen Investigational Site
Oklahoma City, Oklahoma, United States
VistaGen Investigational Site
Media, Pennsylvania, United States
VistaGen Investigational Site
Houston, Texas, United States
VistaGen Investigational Site
Houston, Texas, United States
VistaGen Investigational Site
Bellevue, Washington, United States
Countries
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Other Identifiers
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VSG-CL 003
Identifier Type: -
Identifier Source: org_study_id
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