Clinical trial NCT04634669: Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
Official title: An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With 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
Dextromethorphan
Bupropion
MDD
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD) and major depressive disorder (MDD).

Detailed description: Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.

Eligibility criteria: * Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features
* Continued depression despite treatment with antidepressants in the current depressive episode
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply

Primary outcomes:
measure: Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05
timeFrame: Up to 15 months
Secondary outcomes:
Other outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Up to 15 months
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: Friendswood
country: United States
facility: Clinical Research Site
state: Texas
city: Everett
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References: