Trials / Completed
CompletedNCT03078322
AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- VistaGen Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the safety and efficacy of AV-101.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AV-101 | Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| DRUG | Placebo | Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
Timeline
- Start date
- 2018-03-05
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2017-03-13
- Last updated
- 2019-10-09
Locations
22 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03078322. Inclusion in this directory is not an endorsement.