Actively Recruiting
A Randomized, Double-blind, Active-controlled Study of AXS-05 Compared to Bupropion for Preventing Relapse of Depressive Symptoms in Major Depressive Disorder
Led by Axsome Therapeutics, Inc. · Updated on 2025-01-23
350
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of AXS-05 compared to bupropion in preventing the return of depressive symptoms in adults with major depressive disorder (MDD) who have already responded to treatment with AXS-05. This is a randomized, double-blind, active-controlled study conducted across multiple centers, aiming to assess relapse prevention in people diagnosed with MDD without psychotic features. Participants will first receive open-label AXS-05 treatment for up to 10 weeks, during which their response and remission will be monitored. Those who meet response and remission criteria will then be randomly assigned to continue taking AXS-05 or switch to bupropion tablets, both taken twice daily, for a double-blind treatment period lasting up to 26 weeks or until depressive symptoms relapse. Throughout the study, participants will be closely monitored for signs of depressive symptom relapse using regular assessments. The main outcome measured is the time from randomization to relapse over the 26-week double-blind period. The entire study period includes an initial 10-week treatment phase followed by up to 26 weeks of randomized treatment, with ongoing evaluation by the study team to track safety and treatment effects.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently meets DSM-5 criteria for diagnosis of major depressive disorder without psychotic features
- Has a current major depressive episode lasting at least 4 weeks
- Is between 18 and 65 years old
You will not qualify if you...
- Previously participated in another clinical study of AXS-05
- Received any investigational drug or device treatment within 30 days before screening
- Has been prescribed Auvelity
- Unable to comply with study procedures
- Medically inappropriate for study participation as judged by the investigator or doctor in charge of the study care team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 weeks
Participants receive open-label AXS-05 and are monitored for response and remission of depressive symptoms.
Regular visits during treatment period
Duration - Up to 26 weeks or until relapse
Participants who respond to open-label treatment are randomized to continue AXS-05 or switch to bupropion to prevent relapse of depressive symptoms.
Regular visits during treatment period
Trial Site Locations
Total: 40 locations
1
Clinical Research Site
Bellflower, California, United States, 90706
Actively Recruiting
2
Clinical Research Site
Lafayette, California, United States, 94549
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3
Clinical Research Site
Oceanside, California, United States, 92056
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4
Clinical Research Site
Redlands, California, United States, 92374
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5
Clinical Research Site
Riverside, California, United States, 92506
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6
Clinical Research Site
San Diego, California, United States, 92103
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7
Clinical Research Site
Upland, California, United States, 91786
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8
Clinical Research Site
Brandon, Florida, United States, 33511
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9
Clinical Research Site
Doral, Florida, United States, 33122
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10
Clinical Research Site
Hialeah, Florida, United States, 33012
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11
Clinical Research Site
Jacksonville, Florida, United States, 32256
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12
Clinical Research Site
Miami, Florida, United States, 33122
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13
Clinical Research Site
Orlando, Florida, United States, 32801
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14
Clinical Research Site
Orlando, Florida, United States, 32806
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15
Clinical Research Site
Orlando, Florida, United States, 32807
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16
Clinical Research Site
Atlanta, Georgia, United States, 30331
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17
Clinical Research Site
Chicago, Illinois, United States, 60634
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18
Clinical Research Site
Overland Park, Kansas, United States, 66210
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19
Clinical Research Site
New Orleans, Louisiana, United States, 70115
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20
Clinical Research Site
Boston, Massachusetts, United States, 02131
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21
Clinical Research Site
Saint Charles, Missouri, United States, 63304
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22
Clinical Research Site
Las Vegas, Nevada, United States, 89102
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23
Clinical Research Site
Cherry Hill, New Jersey, United States, 08002
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24
Clinical Research Site
Toms River, New Jersey, United States, 08755
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25
Clinical Research Site
Brooklyn, New York, United States, 11235
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26
Clinical Research Site
Mount Kisco, New York, United States, 10549
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27
Clinical Research Site
New York, New York, United States, 10128
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28
Clinical Research Site
Staten Island, New York, United States, 10314
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29
Clinical Research Site
Hickory, North Carolina, United States, 28601
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30
Clinical Research Site
Cincinnati, Ohio, United States, 45215
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31
Clinical Research Site
Edmond, Oklahoma, United States, 73013
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32
Clinical Research Site
Oklahoma City, Oklahoma, United States, 73118
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33
Clinical Research Site
Portland, Oregon, United States, 97210
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34
Clinical Research Site
Memphis, Tennessee, United States, 38119
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35
Clinical Research Site
Dallas, Texas, United States, 75231
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36
Clinical Research Site
Dallas, Texas, United States, 75243
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37
Clinical Research Site
Friendswood, Texas, United States, 77546
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38
Clinical Research Site
San Antonio, Texas, United States, 78229
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39
Clinical Research Site
Wichita Falls, Texas, United States, 76309
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40
Clinical Research Site
Everett, Washington, United States, 98201
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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