Mechanistic Evaluation of Response in TRD (MERIT)

Sponsor

Axsome Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04608396

Collaborator

(none)

Enrollment

Locations

Arms

11.5

Actual Duration (Months)

2.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Depression Major Depressive Disorder	Drug: AXS-05 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 13, 2020

Actual Primary Completion Date :

Jul 30, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXS-05	Drug: AXS-05 AXS-05 taken daily for up to 52 weeks, until relapse.
Placebo Comparator: Placebo	Drug: Placebo Placebo taken daily for up to 52 weeks, until relapse.

Arm

Intervention/Treatment

Experimental: AXS-05

Drug: AXS-05

AXS-05 taken daily for up to 52 weeks, until relapse.

Placebo Comparator: Placebo

Drug: Placebo

Placebo taken daily for up to 52 weeks, until relapse.

Outcome Measures

Primary Outcome Measures

Relapse [Time from randomization to first relapse (up to 52 weeks)]
Assessed by clinician-rated scales.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Little Rock	Arkansas	United States	72209
2	Clinical Research Site	Redlands	California	United States	92374
3	Clinical Research Site	Sherman Oaks	California	United States	91403
4	Clinical Research Site	Upland	California	United States	91786
5	Clinical Research Site	Miami	Florida	United States	33122
6	Clinical Research Site	North Miami	Florida	United States	33161
7	Clinical Research Site	Orlando	Florida	United States	32801
8	Clinical Research Site	Chicago	Illinois	United States	606346
9	Clinical Research Site	Boston	Massachusetts	United States	02131
10	Clinical Research Site	Berlin	New Jersey	United States	08009
11	Clinical Research Site	Rochester	New York	United States	14618
12	Clinical Research Site	Staten Island	New York	United States	10312
13	Clinical Research Site	Hickory	North Carolina	United States	28601
14	Clinical Research Site	Raleigh	North Carolina	United States	27609
15	Clinical Research Site	Cincinnati	Ohio	United States	45215
16	Clinical Research Site	Middleburg Heights	Ohio	United States	44130
17	Clinical Research Site	Media	Pennsylvania	United States	19063
18	Clinical Research Site	Dallas	Texas	United States	75243
19	Clinical Research Site	Houston	Texas	United States	77058
20	Clinical Research Site	Everett	Washington	United States	98201