A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
1 other identifier
interventional
350
1 country
40
Brief Summary
This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Dec 2023
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 27, 2023
CompletedFirst Submitted
Initial submission to the registry
January 16, 2024
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJanuary 23, 2025
January 1, 2025
2.2 years
January 16, 2024
January 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomization to relapse of depressive symptoms
up to 26 weeks
Study Arms (2)
AXS-05
EXPERIMENTALAXS-05 tablets, taken twice daily
Bupropion
ACTIVE COMPARATORBupropion tablets, taken twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- Current major depressive episode of at least 4 weeks in duration
You may not qualify if:
- Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Clinical Research Site
Bellflower, California, 90706, United States
Clinical Research Site
Lafayette, California, 94549, United States
Clinical Research Site
Oceanside, California, 92056, United States
Clinical Research Site
Redlands, California, 92374, United States
Clinical Research Site
Riverside, California, 92506, United States
Clinical Research Site
San Diego, California, 92103, United States
Clinical Research Site
Upland, California, 91786, United States
Clinical Research Site
Brandon, Florida, 33511, United States
Clinical Research Site
Doral, Florida, 33122, United States
Clinical Research Site
Hialeah, Florida, 33012, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Miami, Florida, 33122, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Orlando, Florida, 32806, United States
Clinical Research Site
Orlando, Florida, 32807, United States
Clinical Research Site
Atlanta, Georgia, 30331, United States
Clinical Research Site
Chicago, Illinois, 60634, United States
Clinical Research Site
Overland Park, Kansas, 66210, United States
Clinical Research Site
New Orleans, Louisiana, 70115, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Saint Charles, Missouri, 63304, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Cherry Hill, New Jersey, 08002, United States
Clinical Research Site
Toms River, New Jersey, 08755, United States
Clinical Research Site
Brooklyn, New York, 11235, United States
Clinical Research Site
Mount Kisco, New York, 10549, United States
Clinical Research Site
New York, New York, 10128, United States
Clinical Research Site
Staten Island, New York, 10314, United States
Clinical Research Site
Hickory, North Carolina, 28601, United States
Clinical Research Site
Cincinnati, Ohio, 45215, United States
Clinical Research Site
Edmond, Oklahoma, 73013, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73118, United States
Clinical Research Site
Portland, Oregon, 97210, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Dallas, Texas, 75231, United States
Clinical Research Site
Dallas, Texas, 75243, United States
Clinical Research Site
Friendswood, Texas, 77546, United States
Clinical Research Site
San Antonio, Texas, 78229, United States
Clinical Research Site
Wichita Falls, Texas, 76309, United States
Clinical Research Site
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2024
First Posted
January 25, 2024
Study Start
December 27, 2023
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
January 23, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share