Clinical trial NCT04608396: Mechanistic Evaluation of Response in TRD (MERIT)
Official title: MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Relapse
timeFrame: Time from randomization to first relapse (up to 52 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Research Site
state: Arkansas
city: Redlands
country: United States
facility: Clinical Research Site
state: California
city: Sherman Oaks
country: United States
facility: Clinical Research Site
state: California
city: Upland
country: United States
facility: Clinical Research Site
state: California
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: North Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Chicago
country: United States
facility: Clinical Research Site
state: Illinois
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Berlin
country: United States
facility: Clinical Research Site
state: New Jersey
city: Rochester
country: United States
facility: Clinical Research Site
state: New York
city: Staten Island
country: United States
facility: Clinical Research Site
state: New York
city: Hickory
country: United States
facility: Clinical Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Clinical Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Site
state: Ohio
city: Media
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: Houston
country: United States
facility: Clinical Research Site
state: Texas
city: Everett
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References: