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NCT04608396 · ClinicalTrials.gov registry record · Phase 2
Mechanistic Evaluation of Response in TRD (MERIT)
A Phase 2 study of Major Depressive Disorder and Treatment-Resistant Depression, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 20
- Study locations
NCT04608396: Completed Phase 2 study of Major Depressive Disorder and Treatment-Resistant Depression, sponsored by Axsome Therapeutics.
NCT04608396 is a Phase 2 study of Major Depressive Disorder and Treatment-Resistant Depression that has completed, run by Axsome Therapeutics. The registered enrollment target is 44 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04608396, a Phase 2 study of Major Depressive Disorder and Treatment-Resistant Depression, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Assessed by clinician-rated scales.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AXS-05
Study Locations (20)
California
- Clinical Research Site - Redlands
- Clinical Research Site - Sherman Oaks
- Clinical Research Site - Upland
Florida
- Clinical Research Site - Miami
- Clinical Research Site - North Miami
- Clinical Research Site - Orlando
New York
- Clinical Research Site - Rochester
- Clinical Research Site - Staten Island
North Carolina
- Clinical Research Site - Hickory
- Clinical Research Site - Raleigh
Ohio
- Clinical Research Site - Cincinnati
- Clinical Research Site - Middleburg Heights
Texas
- Clinical Research Site - Dallas
- Clinical Research Site - Houston
Arkansas
- Clinical Research Site - Little Rock
Illinois
- Clinical Research Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 2 |
What the finished NCT04608396 record still lists
NCT04608396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04608396 names 20 study sites across 12 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT04608396 about?
NCT04608396 is a clinical study titled "Mechanistic Evaluation of Response in TRD (MERIT)". 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 stab...
What is the current status of trial NCT04608396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2020-08-13. Estimated completion is 2021-07-30.
What conditions does trial NCT04608396 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Treatment-Resistant Depression.
What interventions are being tested in trial NCT04608396?
The interventions under investigation include: Placebo (DRUG), AXS-05 (DRUG).
Who is sponsoring clinical trial NCT04608396?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04608396 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04608396's enrollment target sits among peer trials
44 192nd of 282 higher than 90 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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