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

VistaGen Therapeutics

Status and phase

Completed

Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: AV-101

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

VSG-CL 003

Details and patient eligibility

About

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

Enrollment

180 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.