Mechanistic Evaluation of Response in TRD (MERIT)
MERIT
MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression
1 other identifier
interventional
44
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2020
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2020
CompletedFirst Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedJuly 12, 2022
July 1, 2022
12 months
October 7, 2020
July 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse
Assessed by clinician-rated scales.
Time from randomization to first relapse (up to 52 weeks)
Study Arms (2)
AXS-05
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (20)
Clinical Research Site
Little Rock, Arkansas, 72209, United States
Clinical Research Site
Redlands, California, 92374, United States
Clinical Research Site
Sherman Oaks, California, 91403, United States
Clinical Research Site
Upland, California, 91786, United States
Clinical Research Site
Miami, Florida, 33122, United States
Clinical Research Site
North Miami, Florida, 33161, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Chicago, Illinois, 606346, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Berlin, New Jersey, 08009, United States
Clinical Research Site
Rochester, New York, 14618, United States
Clinical Research Site
Staten Island, New York, 10312, United States
Clinical Research Site
Hickory, North Carolina, 28601, United States
Clinical Research Site
Raleigh, North Carolina, 27609, United States
Clinical Research Site
Cincinnati, Ohio, 45215, United States
Clinical Research Site
Middleburg Heights, Ohio, 44130, United States
Clinical Research Site
Media, Pennsylvania, 19063, United States
Clinical Research Site
Dallas, Texas, 75243, United States
Clinical Research Site
Houston, Texas, 77058, United States
Clinical Research Site
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double (Participant, Investigator)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 29, 2020
Study Start
August 13, 2020
Primary Completion
July 30, 2021
Study Completion
July 30, 2021
Last Updated
July 12, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share