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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: AV-101; Drug: Placebo

• Registration Number: NCT03078322
• Lead Sponsor: VistaGen Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-13
• Study Start: 2018-03-05
• Status Verified: 2019-10
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AV-101	AV-101	L-4-chlorokynurenine 1440 mg daily for 14 days
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)	2 weeks	Depression questionnaire

Secondary Outcome Measures

Name	Time	Method
Time course of improvement including response rates	2 weeks	50% improvement on MADRS-10
Safety and tolerability will be assessed by incidence of adverse events (AEs)	2 weeks	Also include EKG, labs etc.

Trial Locations

Locations (1)

VistaGen Investigational Site; 🇺🇸 Bellevue, Washington, United States