DepressionPhase 3GEMININCT04019704
A Trial of AXS-05 in Patients With Major Depressive Disorder
A Phase 3 study testing AXS-05 in people with Depression and Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 43 sites in United States.
Trial summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- AXS-05
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 43 sitesUnited States
- Study dates
- 20 Jun 2019to 5 Dec 2019
- 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
- Age 18 - 65
- Currently meets DSM-5 criteria for MDD
- Body Mass Index between 18 and 40 kg/m^2, inclusive
Who cannot join
- Suicide risk
- History of treatment resistance in current depressive episode
- History of electroconvulsive therapy, 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
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Clinical Research Site
Atlanta, Georgia, 30328
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, 45219
Clinical Research Site
Coral Springs, Florida, 33067
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
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
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
Phoenix, Arizona, 85016
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Riverside, California, 92506
Clinical Research Site
Rochester, New York, 14618
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
About this study
Official title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Read the detailed description
This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- AXS-05, Placebo
- Keywords
- Depressive Disorder, Depressive Disorder, Major, Bupropion, Dextromethorphan, MDD, Dopamine Reuptake Inhibitor, AXS-05, NMDA Receptor Antagonist, Central Nervous System, CNS, Sigma-1 Receptor Agonist, Nicotinic Acetylcholine Receptor Antagonist, Norepinephrine Reuptake Inhibitor, Glutamate Modulator, Axsome Therapeutics, GEMINI, Serotonin Reuptake Inhibitor
- Medical subject headings
- Depression, Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-05Drug
Oral AXS-05 tablets, taken daily for 6 weeks.
PlaceboDrug
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AXS-05 | Experimental | AXS-05 (bupropion and dextromethorphan) oral tablets Receives: Drug: AXS-05 |
| Placebo | Placebo comparator | Placebo oral tablets to match AXS-05 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS Total Score From Baseline to Week 6
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start20 Jun 2019
- Primary completion26 Nov 2019
- Study completion5 Dec 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019704
- Sponsor's protocol ID
- AXS-05-MDD-301
- Acronym
- GEMINI
- Status last verified
- Sep 2022
- First submitted
- 11 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
Publications
Iosifescu DV, Jones A, O'Gorman C, Streicher C, Feliz S, Fava M, Tabuteau H. Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022 May 30;83(4):21m14345. doi: 10.4088/JCP.21m14345.
PubMed 35649167Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PubMed 34510411
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
- AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04019704
- Acronym / sponsor ID
- GEMINI / AXS-05-MDD-301
- Conditions
- Depression, Major Depressive Disorder
- Keywords
- Depressive Disorder, Depressive Disorder, Major, Bupropion, Dextromethorphan, MDD, Dopamine Reuptake Inhibitor, AXS-05, NMDA Receptor Antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 15 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.
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Detailed description
This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-05 | Experimental | Drug: AXS-05AXS-05 (bupropion and dextromethorphan) oral tablets |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral tablets to match AXS-05 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 65
- Currently meets DSM-5 criteria for MDD
- Body Mass Index between 18 and 40 kg/m^2, inclusive
Key exclusion criteria (4 listed)
- Suicide risk
- History of treatment resistance in current depressive episode
- History of electroconvulsive therapy, 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
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-05Oral AXS-05 tablets, taken daily for 6 weeks. | Drug | AXS-05 |
| PlaceboPlacebo to match oral AXS-05 tablets, taken daily for 6 weeks. | Drug | Placebo |
Primary outcome
Change in MADRS Total Score From Baseline to Week 6
Time frame: 6 weeks
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
Results and safety
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.
- Derived from this study: PubMed 35649167Iosifescu DV, Jones A, O'Gorman C, Streicher C, Feliz S, Fava M, Tabuteau H. Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022 May 30;83(4):21m14345. doi: 10.4088/JCP.21m14345.
- Derived from this study: PubMed 34510411Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-05 in people with Depression and Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 43 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 3 inclusion and 4 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 43 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. Some participants in this study may receive a placebo. 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?
Change in MADRS Total Score From Baseline to Week 6 (time frame: 6 weeks). 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 NCT04019704, which also lists 2 linked publications.
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.