Major Depressive DisorderPhase 4NCT06223880
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
A Phase 4 study testing AXS-05 and Bupropion in people with Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- AXS-05 and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 40 sitesUnited States
- Study dates
- 27 Dec 2023to Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- Current major depressive episode of at least 4 weeks in duration
Who cannot join
- 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
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
United States40 sites, 40 recruiting
- Recruiting
Clinical Research Site
Atlanta, Georgia, 30331
- Recruiting
Clinical Research Site
Bellflower, California, 90706
- Recruiting
Clinical Research Site
Boston, Massachusetts, 02131
- Recruiting
Clinical Research Site
Brandon, Florida, 33511
- Recruiting
Clinical Research Site
Brooklyn, New York, 11235
- Recruiting
Clinical Research Site
Cherry Hill, New Jersey, 08002
- Recruiting
Clinical Research Site
Chicago, Illinois, 60634
- Recruiting
Clinical Research Site
Cincinnati, Ohio, 45215
- Recruiting
Clinical Research Site
Dallas, Texas, 75231
- Recruiting
Clinical Research Site
Dallas, Texas, 75243
- Recruiting
Clinical Research Site
Doral, Florida, 33122
- Recruiting
Clinical Research Site
Edmond, Oklahoma, 73013
- Recruiting
Clinical Research Site
Everett, Washington, 98201
- Recruiting
Clinical Research Site
Friendswood, Texas, 77546
- Recruiting
Clinical Research Site
Hialeah, Florida, 33012
- Recruiting
Clinical Research Site
Hickory, North Carolina, 28601
- Recruiting
Clinical Research Site
Jacksonville, Florida, 32256
- Recruiting
Clinical Research Site
Lafayette, California, 94549
- Recruiting
Clinical Research Site
Las Vegas, Nevada, 89102
- Recruiting
Clinical Research Site
Memphis, Tennessee, 38119
- Recruiting
Clinical Research Site
Miami, Florida, 33122
- Recruiting
Clinical Research Site
Mount Kisco, New York, 10549
- Recruiting
Clinical Research Site
New Orleans, Louisiana, 70115
- Recruiting
Clinical Research Site
New York, New York, 10128
- Recruiting
Clinical Research Site
Oceanside, California, 92056
- Recruiting
Clinical Research Site
Oklahoma City, Oklahoma, 73118
- Recruiting
Clinical Research Site
Orlando, Florida, 32801
- Recruiting
Clinical Research Site
Orlando, Florida, 32806
- Recruiting
Clinical Research Site
Orlando, Florida, 32807
- Recruiting
Clinical Research Site
Overland Park, Kansas, 66210
- Recruiting
Clinical Research Site
Portland, Oregon, 97210
- Recruiting
Clinical Research Site
Redlands, California, 92374
- Recruiting
Clinical Research Site
Riverside, California, 92506
- Recruiting
Clinical Research Site
Saint Charles, Missouri, 63304
- Recruiting
Clinical Research Site
San Antonio, Texas, 78229
- Recruiting
Clinical Research Site
San Diego, California, 92103
- Recruiting
Clinical Research Site
Staten Island, New York, 10314
- Recruiting
Clinical Research Site
Toms River, New Jersey, 08755
- Recruiting
Clinical Research Site
Upland, California, 91786
- Recruiting
Clinical Research Site
Wichita Falls, Texas, 76309
About this study
Official title: A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
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.
Read the detailed description
Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.
- Conditions
- Major Depressive Disorder
- Being tested
- AXS-05, Bupropion
- Keywords
- AXS-05, Dextromethorphan, Bupropion, MDD, Depression, Relapse of depressive symptoms, NMDA receptor antagonist, Sigma-1 receptor agonist, Norepinephrine reuptake inhibitor, Dopamine reuptake inhibitor, Axsome Therapeutics
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-05Drug
Up to 10 weeks in open-label period;
Up to 26 weeks in double-blind period
BupropionDrug
Up to 26 weeks in double-blind period
| Study group | Role | What they receive |
|---|---|---|
| AXS-05 | Experimental | AXS-05 tablets, taken twice daily Receives: Drug: AXS-05 |
| Bupropion | Active comparator | Bupropion tablets, taken twice daily Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to relapse of depressive symptoms
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start27 Dec 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223880
- Sponsor's protocol ID
- AXS-05-MDD-401
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
- ClinicalTrials.gov ID
- NCT06223880
- Acronym / sponsor ID
- AXS-05-MDD-401
- Conditions
- Major Depressive Disorder
- Keywords
- AXS-05, Dextromethorphan, Bupropion, MDD, Depression, Relapse of depressive symptoms, NMDA receptor antagonist, Sigma-1 receptor agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-05 | Experimental | Drug: AXS-05AXS-05 tablets, taken twice daily |
| Bupropion | Active comparator | Drug: BupropionBupropion tablets, taken twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- Current major depressive episode of at least 4 weeks in duration
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXS-05Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period | Drug | AXS-05 |
| BupropionUp to 26 weeks in double-blind period | Drug | Bupropion |
Primary outcome
Time from randomization to relapse of depressive symptoms
Time frame: up to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AXS-05 and Bupropion in people with Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (+1 (212) 332-5061, axs-05-mdd-401@axsome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomization to relapse of depressive symptoms (time frame: up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.