Clinical trial NCT04019704: A Trial of AXS-05 in Patients With Major Depressive Disorder
Official title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Major Depressive Disorder
Keywords: Depressive Disorder
Depressive Disorder, Major
Bupropion
Dextromethorphan
MDD
Dopamine Reuptake Inhibitor
AXS-05
NMDA Receptor Antagonist
Central Nervous System
CNS
Sigma-1 Receptor Agonist
Nicotinic Acetylcholine Receptor Antagonist
Norepinephrine Reuptake Inhibitor
Glutamate Modulator
Axsome Therapeutics
GEMINI
Serotonin Reuptake Inhibitor
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 327
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: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Detailed description: This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Eligibility criteria: Key Inclusion Criteria:

* Age 18 - 65
* Currently meets DSM-5 criteria for MDD
* Body Mass Index between 18 and 40 kg/m\^2, inclusive

Key Exclusion Criteria:

* Suicide risk
* History of treatment resistance in current depressive episode
* History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Primary outcomes:
measure: Change in MADRS Total Score From Baseline to Week 6
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Research Site
state: Arizona
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: 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: Riverside
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: Coral Springs
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: 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: 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: 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: 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: 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:
citation: Iosifescu DV, Jones A, O'Gorman C, Streicher C, Feliz S, Fava M, Tabuteau H. Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022 May 30;83(4):21m14345. doi: 10.4088/JCP.21m14345.
citation: Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.