Clinical trial NCT04039022: Open-Label Safety Study of AXS-05 in Subjects With Depression
Official title: An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Treatment Resistant Depression
Depression
Keywords: Depression
AXS-05
Dextromethorphan
Bupropion
Dopamine Reuptake Inhibitor
NMDA Receptor Antagonist
Nicotinic Acetylcholine Receptor Antagonist
Serotonin Reuptake Inhibitor
Axsome Therapeutics
Norepinephrine Reuptake Inhibitor
Sigma-1 Receptor Agonist
Glutamate Modulator
Antidepressant
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-31
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

Detailed description: A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of major depressive disorder, including treatment resistant depression
* Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Suicide risk
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
* Additional criteria may apply

Primary outcomes:
measure: Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Research Site
state: Arizona
city: Little Rock
country: United States
facility: Clinical Research Site
state: Arkansas
city: Bellflower
country: United States
facility: Clinical Research Site
state: California
city: Beverly Hills
country: United States
facility: Clinical Research Site
state: California
city: Culver City
country: United States
facility: Clinical Research Site
state: California
city: Garden Grove
country: United States
facility: Clinical Research Site
state: California
city: Oakland
country: United States
facility: Clinical Research Site
state: California
city: Oceanside
country: United States
facility: Clinical Research Site
state: California
city: Panorama City
country: United States
facility: Clinical Research Site
state: California
city: Redlands
country: United States
facility: Clinical Research Site
state: California
city: San Diego
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: Cromwell
country: United States
facility: Clinical Research Site
state: Connecticut
city: Coral Springs
country: United States
facility: Clinical Research Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: Hollywood
country: United States
facility: Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Lauderhill
country: United States
facility: Clinical Research Site
state: Florida
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: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Boise
country: United States
facility: Clinical Research Site
state: Idaho
city: Chicago
country: United States
facility: Clinical Research Site
state: Illinois
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Berlin
country: United States
facility: Clinical Research Site
state: New Jersey
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: Jamaica
country: United States
facility: Clinical Research Site
state: New York
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: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Media
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: Fort Worth
country: United States
facility: Clinical Research Site
state: Texas
city: Houston
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: Bellevue
country: United States
facility: Clinical Research Site
state: Washington
city: Everett
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References: