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A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-05 | Experimental | AXS-05 (bupropion and dextromethorphan) oral tablets |
|
| Placebo | Placebo Comparator | Placebo oral tablets to match AXS-05 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-05 | Drug | Oral AXS-05 tablets, taken daily for 6 weeks. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Phoenix | Arizona | 85012 | United States | ||
| Clinical Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35649167 | Derived | 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. | |
| 34510411 | Derived |
| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXS-05 | AXS-05 (bupropion and dextromethorphan) oral tablets AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks. |
| FG001 | Placebo | Placebo oral tablets to match AXS-05 Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2019 |
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| Drug |
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks. |
|
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Clinical Research Site | Little Rock | Arkansas | 72209 | United States |
| Clinical Research Site | Bellflower | California | 90706 | United States |
| Clinical Research Site | Beverly Hills | California | 90210 | United States |
| Clinical Research Site | Garden Grove | California | 92845 | United States |
| Clinical Research Site | Oakland | California | 94607 | United States |
| Clinical Research Site | Oceanside | California | 92056 | United States |
| Clinical Research Site | Panorama City | California | 91402 | 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 | Sherman Oaks | California | 91403 | United States |
| Clinical Research Site | Upland | California | 91786 | United States |
| Clinical Research Site | Coral Springs | Florida | 33067 | United States |
| Clinical Research Site | Hollywood | Florida | 33024 | United States |
| Clinical Research Site | Jacksonville | Florida | 32256 | United States |
| Clinical Research Site | Lauderhill | Florida | 33319 | United States |
| Clinical Research Site | North Miami | Florida | 33161 | United States |
| Clinical Research Site | Orlando | Florida | 32801 | United States |
| Clinical Research Site | Atlanta | Georgia | 30328 | United States |
| Clinical Research Site | Boise | Idaho | 83704 | United States |
| Clinical Research Site | Chicago | Illinois | 60634 | United States |
| Clinical Research Site | Boston | Massachusetts | 02131 | United States |
| Clinical Research Site | Las Vegas | Nevada | 89102 | United States |
| Clinical Research Site | Berlin | New Jersey | 08009 | 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 | Jamaica | New York | 11432 | United States |
| Clinical Research Site | Rochester | New York | 14618 | United States |
| Clinical Research Site | Staten Island | New York | 10312 | United States |
| Clinical Research Site | Hickory | North Carolina | 28601 | United States |
| Clinical Research Site | Cincinnati | Ohio | 45219 | United States |
| Clinical Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Clinical Research Site | Media | Pennsylvania | 19063 | United States |
| Clinical Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Research Site | Memphis | Tennessee | 38119 | United States |
| Clinical Research Site | Dallas | Texas | 75243 | United States |
| Clinical Research Site | Fort Worth | Texas | 76104 | United States |
| Clinical Research Site | Houston | Texas | 77058 | United States |
| Clinical Research Site | Wichita Falls | Texas | 76309 | United States |
| Clinical Research Site | Everett | Washington | 98201 | United States |
| Dean 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. |
| COMPLETED |
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| NOT COMPLETED |
|
Participants randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | AXS-05 | AXS-05 (bupropion and dextromethorphan) oral tablets AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks. |
| BG001 | Placebo | Placebo oral tablets to match AXS-05 Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | modified Intent-to-Treat (mITT) Population | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks |
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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 dose.
Safety Population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AXS-05 | AXS-05 (bupropion and dextromethorphan) oral tablets AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks. | 0 | 162 | 1 | 162 | 100 | 162 |
| EG001 | Placebo | Placebo oral tablets to match AXS-05 Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks. | 0 | 164 | 0 | 164 | 74 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment | Not related to study drug. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| All Others, occurring in <5% of Subjects | General disorders | MedDRA Dictionary | Non-systematic Assessment | All other events |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Streicher, Senior Director, Clinical Operations | Axsome Therapeutics, Inc. | 212-332-5061 | cstreicher@axsome.com |
| Sep 16, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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