A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
STRIDE-1
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
1 other identifier
interventional
312
1 country
74
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Typical duration for phase_3
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 5, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2020
CompletedMarch 24, 2021
March 1, 2021
4.1 years
April 5, 2016
March 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery-Ă…sberg Depression Rating Scale (MADRS) total score
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
MADRS change from Baseline to End of Study (6 weeks)
Secondary Outcomes (2)
Clinical Global Impressions-Severity (CGI-S)
Baseline to End of Study (6 weeks)
Hamilton Depression Rating Scale - 17 items (HAMD-17)
Baseline to End of Study (6 weeks)
Study Arms (2)
AXS-05
EXPERIMENTALBupropion
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Garden Grove, California, United States
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Oakland, California, United States
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Oceanside, California, United States
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Panorama City, California, United States
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Redlands, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Sherman Oaks, California, United States
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Temecula, California, United States
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Upland, California, United States
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Colorado Springs, Colorado, United States
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Cromwell, Connecticut, United States
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Washington D.C., District of Columbia, 20016, United States
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Coral Springs, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, 32256, United States
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Lakeland, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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St. Petersburg, Florida, United States
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Atlanta, Georgia, 30328, United States
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Boise, Idaho, United States
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Skokie, Illinois, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Berlin, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Marlton, New Jersey, United States
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Princeton, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Jamaica, New York, 11432, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Charlotte, North Carolina, United States
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Canton, Ohio, United States
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Dayton, Ohio, United States
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Middleburg Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Allentown, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, 38119, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Orem, Utah, United States
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Charlottesville, Virginia, United States
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Herndon, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Waukesha, Wisconsin, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 18, 2016
Study Start
March 1, 2016
Primary Completion
March 20, 2020
Study Completion
March 20, 2020
Last Updated
March 24, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share