Clinical trial NCT02741791: A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
Official title: STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Treatment Resistant Major Depressive Disorder
Keywords: AXS-05
Major Depressive Disorder
Treatment Resistant Depression
TRD
MDD
Axsome
NMDA receptor
Refractory depression
Resistant depression
Depression
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 312
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: To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).

This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.

Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.


Eligibility criteria: Key Inclusion Criteria:

* Currently meets DSM-V criteria for MDD
* History of inadequate response to 1 or 2 adequate antidepressant treatments
* Body mass index (BMI) between 18 and 40 kg/m2, inclusive
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply

Key Exclusion Criteria:

* Suicide risk
* Treatment with any investigational drug within 6 months
* History of electroconvulsive therapy (ECT), 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
* Additional criteria may apply

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) total score
timeFrame: MADRS change from Baseline to End of Study (6 weeks)
Secondary outcomes:
measure: Clinical Global Impressions-Severity (CGI-S)
timeFrame: Baseline to End of Study (6 weeks)
measure: Hamilton Depression Rating Scale - 17 items (HAMD-17)
timeFrame: Baseline to End of Study (6 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Panorama City
country: United States
state: California
city: Redlands
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Sherman Oaks
country: United States
state: California
city: Temecula
country: United States
state: California
city: Upland
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Cromwell
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Coral Springs
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Skokie
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Saint Charles
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Nashua
country: United States
state: New Hampshire
city: Berlin
country: United States
state: New Jersey
city: Cherry Hill
country: United States
state: New Jersey
city: Marlton
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Media
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Lincoln
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Herndon
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Waukesha
country: United States
state: Wisconsin
Study officials:
References: