Clinical trial NCT03078322: AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: VistaGen Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)
timeFrame: 2 weeks
Secondary outcomes:
measure: Time course of improvement including response rates
timeFrame: 2 weeks
measure: Safety and tolerability will be assessed by incidence of adverse events (AEs)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: VistaGen Investigational Site
state: California
city: Los Angeles
country: United States
facility: VistaGen Investigational Site
state: California
city: National City
country: United States
facility: VistaGen Investigational Site
state: California
city: Oakland
country: United States
facility: VistaGen Investigational Site
state: California
city: San Diego
country: United States
facility: VistaGen Investigational Site
state: California
city: Temecula
country: United States
facility: VistaGen Investigational Site
state: California
city: Fort Myers
country: United States
facility: VistaGen Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: VistaGen Investigational Site
state: Florida
city: Atlanta
country: United States
facility: VistaGen Investigational Site
state: Georgia
city: Augusta
country: United States
facility: VistaGen Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: VistaGen Investigational Site
state: Illinois
city: Lake Charles
country: United States
facility: VistaGen Investigational Site
state: Louisiana
city: Gaithersburg
country: United States
facility: VistaGen Investigational Site
state: Maryland
city: Saint Louis
country: United States
facility: VistaGen Investigational Site
state: Missouri
city: New York
country: United States
facility: VistaGen Investigational Site
state: New York
city: Rochester
country: United States
facility: VistaGen Investigational Site
state: New York
city: Dayton
country: United States
facility: VistaGen Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: VistaGen Investigational Site
state: Oklahoma
city: Media
country: United States
facility: VistaGen Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: VistaGen Investigational Site
state: Texas
city: Houston
country: United States
facility: VistaGen Investigational Site
state: Texas
city: Bellevue
country: United States
facility: VistaGen Investigational Site
state: Washington
Study officials:
References: