Trials / Completed
CompletedNCT04608396
Mechanistic Evaluation of Response in TRD (MERIT)
MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Axsome Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AXS-05 | AXS-05 taken daily for up to 52 weeks, until relapse. |
| DRUG | Placebo | Placebo taken daily for up to 52 weeks, until relapse. |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2021-07-30
- Completion
- 2021-07-30
- First posted
- 2020-10-29
- Last updated
- 2022-07-12
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04608396. Inclusion in this directory is not an endorsement.