Trials / Completed
CompletedNCT04832425
A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder
A Phase 2/3 Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Praxis Precision Medicines · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRAX-114 | 40 mg once daily |
| DRUG | Placebo | Placebo once daily |
Timeline
- Start date
- 2021-03-30
- Primary completion
- 2022-05-05
- Completion
- 2022-05-05
- First posted
- 2021-04-05
- Last updated
- 2022-07-21
Locations
31 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04832425. Inclusion in this directory is not an endorsement.