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

Major Depressive Disorder Clinical Trial

— ELEVATE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078322
• Other study ID #: VSG-CL 003
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2019
• Source: VistaGen Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	VistaGen Investigational Site	Atlanta	Georgia
United States	VistaGen Investigational Site	Augusta	Georgia
United States	VistaGen Investigational Site	Bellevue	Washington
United States	VistaGen Investigational Site	Dayton	Ohio
United States	VistaGen Investigational Site	Fort Myers	Florida
United States	VistaGen Investigational Site	Gaithersburg	Maryland
United States	VistaGen Investigational Site	Garden Grove	California
United States	VistaGen Investigational Site	Hoffman Estates	Illinois
United States	VistaGen Investigational Site	Houston	Texas
United States	VistaGen Investigational Site	Houston	Texas
United States	VistaGen Investigational Site	Jacksonville	Florida
United States	VistaGen Investigational Site	Lake Charles	Louisiana
United States	VistaGen Investigational Site	Los Angeles	California
United States	VistaGen Investigational Site	Media	Pennsylvania
United States	VistaGen Investigational Site	National City	California
United States	VistaGen Investigational Site	New York	New York
United States	VistaGen Investigational Site	Oakland	California
United States	VistaGen Investigational Site	Oklahoma City	Oklahoma
United States	VistaGen Investigational Site	Rochester	New York
United States	VistaGen Investigational Site	Saint Louis	Missouri
United States	VistaGen Investigational Site	San Diego	California
United States	VistaGen Investigational Site	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
VistaGen Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)	Depression questionnaire	2 weeks
Secondary	Time course of improvement including response rates	50% improvement on MADRS-10	2 weeks
Secondary	Safety and tolerability will be assessed by incidence of adverse events (AEs)	Also include EKG, labs etc.	2 weeks