Clinical trial NCT06223880: A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
Official title: A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: AXS-05
Dextromethorphan
Bupropion
MDD
Depression
Relapse of depressive symptoms
NMDA receptor antagonist
Sigma-1 receptor agonist
Norepinephrine reuptake inhibitor
Dopamine reuptake inhibitor
Axsome Therapeutics
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.

Detailed description: Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.

Eligibility criteria: Inclusion Criteria:

* Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
* Current major depressive episode of at least 4 weeks in duration

Exclusion Criteria:

* Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.
* Unable to comply with study procedures
* Medically inappropriate for study participation in the opinion of the investigator

Primary outcomes:
measure: Time from randomization to relapse of depressive symptoms
timeFrame: up to 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: Clinical Research Site
state: California
city: Lafayette
country: United States
facility: Clinical Research Site
state: California
city: Oceanside
country: United States
facility: Clinical Research Site
state: California
city: Redlands
country: United States
facility: Clinical Research Site
state: California
city: Riverside
country: United States
facility: Clinical Research Site
state: California
city: San Diego
country: United States
facility: Clinical Research Site
state: California
city: Upland
country: United States
facility: Clinical Research Site
state: California
city: Brandon
country: United States
facility: Clinical Research Site
state: Florida
city: Doral
country: United States
facility: Clinical Research Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Chicago
country: United States
facility: Clinical Research Site
state: Illinois
city: Overland Park
country: United States
facility: Clinical Research Site
state: Kansas
city: New Orleans
country: United States
facility: Clinical Research Site
state: Louisiana
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Saint Charles
country: United States
facility: Clinical Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Cherry Hill
country: United States
facility: Clinical Research Site
state: New Jersey
city: Toms River
country: United States
facility: Clinical Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Clinical Research Site
state: New York
city: Mount Kisco
country: United States
facility: Clinical Research Site
state: New York
city: New York
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: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Edmond
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Portland
country: United States
facility: Clinical Research Site
state: Oregon
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: Friendswood
country: United States
facility: Clinical Research Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Clinical Research Site
state: Texas
city: Everett
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References: