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NCT04608396 Clinical Trial

Mechanistic Evaluation of Response in TRD (MERIT)

Major Depressive Disorder Clinical Trial

— MERIT  

Official title:
MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04608396
Other study ID # AXS-05-TRD-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 13, 2020
Est. completion date July 30, 2021

Study information
Verified date July 2022
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Eligibility Criteria: - Ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving AXS-05 - Agree to use adequate method of contraception for the duration of the study - Additional criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-05
AXS-05 taken daily for up to 52 weeks, until relapse.
• Placebo
Placebo taken daily for up to 52 weeks, until relapse.

Locations
Country Name City State
United States Clinical Research Site Berlin New Jersey
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Chicago Illinois
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Everett Washington
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Houston Texas
United States Clinical Research Site Little Rock Arkansas
United States Clinical Research Site Media Pennsylvania
United States Clinical Research Site Miami Florida
United States Clinical Research Site Middleburg Heights Ohio
United States Clinical Research Site North Miami Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Raleigh North Carolina
United States Clinical Research Site Redlands California
United States Clinical Research Site Rochester New York
United States Clinical Research Site Sherman Oaks California
United States Clinical Research Site Staten Island New York
United States Clinical Research Site Upland California

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relapse Assessed by clinician-rated scales. Time from randomization to first relapse (up to 52 weeks)
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