Major Depressive DisorderPhase 3NCT04039022

Open-Label Safety Study of AXS-05 in Subjects With Depression

A Phase 3 study testing AXS-05 (dextromethorphan and bupropion) oral tablets in people with Major Depressive Disorder and Treatment Resistant Depression, run by Axsome Therapeutics, Inc. at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder, Treatment Resistant Depression, Depression
What is being tested?: AXS-05 (dextromethorphan and bupropion) oral tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 876 participants
Where: 51 sitesUnited States
Study dates: 8 Jul 2019to 23 Oct 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis of major depressive disorder, including treatment resistant depression
Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Agree to use adequate method of contraception for the duration of the study
Additional criteria may apply

Who cannot join

Suicide risk
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Additional criteria may apply

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Clinical Research Site
Atlanta, Georgia, 30328
Clinical Research Site
Atlanta, Georgia, 30331
Clinical Research Site
Austin, Texas, 78712
Clinical Research Site
Bellevue, Washington, 98007
Clinical Research Site
Bellflower, California, 90706
Clinical Research Site
Berlin, New Jersey, 08009
Clinical Research Site
Beverly Hills, California, 90210
Clinical Research Site
Boise, Idaho, 83704
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Cherry Hill, New Jersey, 08002
Clinical Research Site
Chicago, Illinois, 60634
Clinical Research Site
Cincinnati, Ohio, 45215
Clinical Research Site
Cincinnati, Ohio, 45219
Clinical Research Site
Coral Springs, Florida, 33067
Clinical Research Site
Cromwell, Connecticut, 06416
Clinical Research Site
Culver City, California, 90230
Clinical Research Site
Dallas, Texas, 75243
Clinical Research Site
Everett, Washington, 98201
Clinical Research Site
Fort Worth, Texas, 76104
Clinical Research Site
Garden Grove, California, 92845
Clinical Research Site
Hialeah, Florida, 33012
Clinical Research Site
Hickory, North Carolina, 28601
Clinical Research Site
Hollywood, Florida, 33024
Clinical Research Site
Houston, Texas, 77058
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Jamaica, New York, 11432
Clinical Research Site
Las Vegas, Nevada, 89102
Clinical Research Site
Lauderhill, Florida, 33319
Clinical Research Site
Little Rock, Arkansas, 72209
Clinical Research Site
Media, Pennsylvania, 19063
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
Miami, Florida, 33122
Clinical Research Site
Middleburg Heights, Ohio, 44130
Clinical Research Site
North Miami, Florida, 33161
Clinical Research Site
Oakland, California, 94607
Clinical Research Site
Oceanside, California, 92056
Clinical Research Site
Oklahoma City, Oklahoma, 73112
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Panorama City, California, 91402
Clinical Research Site
Philadelphia, Pennsylvania, 19104
Clinical Research Site
Phoenix, Arizona, 85012
Clinical Research Site
Raleigh, North Carolina, 27609
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Rochester, New York, 14618
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
San Diego, California, 92103
Clinical Research Site
Sherman Oaks, California, 91403
Clinical Research Site
Staten Island, New York, 10312
Clinical Research Site
Toms River, New Jersey, 08755
Clinical Research Site
Upland, California, 91786
Clinical Research Site
Wichita Falls, Texas, 76309

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About this study

Official title: An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

Read the detailed description

A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Conditions: Major Depressive Disorder, Treatment Resistant Depression, Depression
Being tested: AXS-05 (dextromethorphan and bupropion) oral tablets
Keywords: Depression, AXS-05, Dextromethorphan, Bupropion, Dopamine Reuptake Inhibitor, NMDA Receptor Antagonist, Nicotinic Acetylcholine Receptor Antagonist, Serotonin Reuptake Inhibitor, Axsome Therapeutics, Norepinephrine Reuptake Inhibitor, Sigma-1 Receptor Agonist, Glutamate Modulator, Antidepressant
Medical subject headings: Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AXS-05 (dextromethorphan and bupropion) oral tabletsDrug
Oral tablets, taken twice daily for up to 12 months.

Study groups in NCT04039022
Study group	Role	What they receive
AXS-05	Experimental	Not described Receives: Drug: AXS-05 (dextromethorphan and bupropion) oral tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
Types and rates of adverse events
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201923 Oct 2020

First posted31 Jul 2019
Study start8 Jul 2019
Primary completion23 Oct 2020
Study completion23 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 876 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04039022
Sponsor's protocol ID: AXS-05-303
Status last verified: Sep 2022
First submitted: 29 Jul 2019
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
ClinicalTrials.gov ID: NCT04039022
Acronym / sponsor ID: AXS-05-303
Conditions: Major Depressive Disorder, Treatment Resistant Depression, Depression
Keywords: Depression, AXS-05, Dextromethorphan, Bupropion, Dopamine Reuptake Inhibitor, NMDA Receptor Antagonist, Nicotinic Acetylcholine Receptor Antagonist, Serotonin Reuptake Inhibitor
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 876 participants (actual)
Lead sponsor: Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 8 Jul 2019 (actual)
Primary completion: 23 Oct 2020 (actual)
Study completion: 23 Oct 2020 (actual)
First posted: 31 Jul 2019 (actual)
Results: Posted 12 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AXS-05	Experimental	Drug: AXS-05 (dextromethorphan and bupropion) oral tablets

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of major depressive disorder, including treatment resistant depression
Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Agree to use adequate method of contraception for the duration of the study
Additional criteria may apply

Key exclusion criteria (3 listed)

Suicide risk
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Additional criteria may apply

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-05 (dextromethorphan and bupropion) oral tabletsOral tablets, taken twice daily for up to 12 months.	Drug	AXS-05

Primary outcome

Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
Time frame: Up to 12 months
Types and rates of adverse events

Results and safety

Results posted to the registry on 12 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AXS-05	876	53

Primary outcome: Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	AXS-05 n = 707
Value	505

Population analysed: Primary Safety Population (subjects who continued beyond Week 6 of the trial)

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last study visit.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AXS-05	21 of 876 (2.4%)	609 of 876 (69.5%)	2 of 876

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04039022.

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 12 Oct 2022.