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Mechanistic Evaluation of Response in TRD (MERIT) (MERIT)

Primary Purpose

Treatment Resistant Depression, Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AXS-05
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Relapse prevention, Dextromethorphan, Bupropion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-05

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Relapse
Assessed by clinician-rated scales.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2020
Last Updated
July 8, 2022
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04608396
Brief Title
Mechanistic Evaluation of Response in TRD (MERIT)
Acronym
MERIT
Official Title
MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Major Depressive Disorder
Keywords
AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Relapse prevention, Dextromethorphan, Bupropion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-05
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AXS-05
Intervention Description
AXS-05 taken daily for up to 52 weeks, until relapse.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken daily for up to 52 weeks, until relapse.
Primary Outcome Measure Information:
Title
Relapse
Description
Assessed by clinician-rated scales.
Time Frame
Time from randomization to first relapse (up to 52 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Clinical Research Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Clinical Research Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Clinical Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Clinical Research Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606346
Country
United States
Facility Name
Clinical Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Clinical Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Clinical Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Clinical Research Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Clinical Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Clinical Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Clinical Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Clinical Research Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Clinical Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Clinical Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Clinical Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

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Mechanistic Evaluation of Response in TRD (MERIT)

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