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

NCT03078322 | Completed Phase 2 FDA Drug

• 1 other identifier: VSG-CL 003
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)

  Depression questionnaire

  2 weeks

Secondary Outcomes (2)

• Time course of improvement including response rates

  2 weeks

• Safety and tolerability will be assessed by incidence of adverse events (AEs)

  2 weeks

Study Arms (2)

AV-101

EXPERIMENTAL

L-4-chlorokynurenine 1440 mg daily for 14 days

Drug: AV-101

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AV-101 DRUG

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

Also known as: L-4-chlorokynurenine

AV-101

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VistaGen Therapeutics, Inc.: lead

Study Sites (22)

VistaGen Investigational Site

Garden Grove, California, 92845, United States

Location

VistaGen Investigational Site

Los Angeles, California, 90024, United States

Location

VistaGen Investigational Site

National City, California, 91950, United States

Location

VistaGen Investigational Site

Oakland, California, 94607, United States

Location

VistaGen Investigational Site

San Diego, California, 92103, United States

Location

VistaGen Investigational Site

Temecula, California, 92591, United States

Location

VistaGen Investigational Site

Fort Myers, Florida, 33912, United States

Location

VistaGen Investigational Site

Jacksonville, Florida, 32256, United States

Location

VistaGen Investigational Site

Atlanta, Georgia, 30331, United States

Location

VistaGen Investigational Site

Augusta, Georgia, 30912, United States

Location

VistaGen Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

VistaGen Investigational Site

Lake Charles, Louisiana, 70629, United States

Location

VistaGen Investigational Site

Gaithersburg, Maryland, 20877, United States

Location

VistaGen Investigational Site

St Louis, Missouri, 63141, United States

Location

VistaGen Investigational Site

New York, New York, 10128, United States

Location

VistaGen Investigational Site

Rochester, New York, 14618, United States

Location

VistaGen Investigational Site

Dayton, Ohio, 45417, United States

Location

VistaGen Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

VistaGen Investigational Site

Media, Pennsylvania, 19063, United States

Location

VistaGen Investigational Site

Houston, Texas, 77030, United States

Location

VistaGen Investigational Site

Houston, Texas, 77058, United States

Location

VistaGen Investigational Site

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: March 5, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)