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This study was terminated once overall program objectives were met.
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This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures
Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-05 (dextromethorphan-bupropion) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-05 (dextromethorphan-bupropion) | Drug | - Titrated to AXS-05 (45 mg dextromethorphan HBr / 105 mg bupropion HCl) twice daily (up to 15 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date. |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Little Rock | Arkansas | 72209 | United States | ||
| Clinical Research Site |
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| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXS-05 | AXS-05 tablet, taken twice daily (up to 15 months) |
| 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 | Yes | No | No | Study Protocol | Nov 8, 2021 | Jan 12, 2026 |
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| Redlands |
| California |
| 92374 |
| United States |
| Clinical Research Site | Sherman Oaks | California | 91403 | United States |
| Clinical Research Site | Upland | California | 91786 | United States |
| Clinical Research Site | Miami | Florida | 33122 | United States |
| Clinical Research Site | Miami Lakes | Florida | 33016 | United States |
| Clinical Research Site | Orlando | Florida | 32081 | United States |
| Clinical Research Site | Chicago | Illinois | 60634 | United States |
| Clinical Research Site | Boston | Massachusetts | 02131 | United States |
| Clinical Research Site | Berlin | New Jersey | 08009 | 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 | Raleigh | North Carolina | 27609 | United States |
| Clinical Research Site | Cincinnati | Ohio | 45215 | United States |
| Clinical Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Research Site | Media | Pennsylvania | 19063 | United States |
| Clinical Research Site | Dallas | Texas | 75243 | United States |
| Clinical Research Site | Friendswood | Texas | 77546 | United States |
| Clinical Research Site | Everett | Washington | 98201 | United States |
|
| COMPLETED | Number of subjects who Completed prior to study termination. |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AXS-05 | AXS-05 tablet, taken twice daily (up to 15 months) |
| 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/Ethnicity, Customized | 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 | Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | Posted | Count of Participants | Participants | Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date. |
|
|
|
Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date.
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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 tablet, taken twice daily for up to 15 months | 0 | 181 | 7 | 181 | 38 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Streicher, Senior Vice President, Clinical Research | Axsome Therapeutics, Inc | 212-332-5061 | cstreicher@axsome.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2022 | Jan 12, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Asian |
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| Other |
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| Multiple |
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| Title | Measurements |
|---|---|
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| Subjects with TEAEs that led to drug withdrawal |
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| Subjects with TEAEs that led to withdrawal from study |
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| Subjects with TEAEs that resulted in death |
|