Trials / Completed
CompletedNCT03595579
Assessing Symptomatic Clinical Episodes in Depression
A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- Axsome Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
Detailed description
This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AXS-05 | AXS-05 taken twice daily for 6 weeks. |
| DRUG | Bupropion | Bupropion taken twice daily for 6 weeks. |
Timeline
- Start date
- 2018-05-30
- Primary completion
- 2019-01-07
- Completion
- 2019-01-07
- First posted
- 2018-07-23
- Last updated
- 2021-09-24
- Results posted
- 2021-09-24
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03595579. Inclusion in this directory is not an endorsement.