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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04608396
The ClinicalTrials.gov registry entry for NCT04608396 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (88% lower). The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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