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An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-05 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-05 (dextromethorphan and bupropion) oral tablets | Drug | Oral tablets, taken twice daily for up to 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 | Types and rates of adverse events | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Phoenix | Arizona | 85012 | United States | ||
| Clinical Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXS-05 | AXS-05: Oral tablets, taken twice daily for up to 12 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2020 |
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| 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 | Culver City | California | 90230 | 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 | 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 | Cromwell | Connecticut | 06416 | United States |
| Clinical Research Site | Coral Springs | Florida | 33067 | United States |
| Clinical Research Site | Hialeah | Florida | 33012 | 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 | Miami | Florida | 33122 | 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 | Atlanta | Georgia | 30331 | 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 | Raleigh | North Carolina | 27609 | United States |
| Clinical Research Site | Cincinnati | Ohio | 45215 | 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 | Austin | Texas | 78712 | 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 | San Antonio | Texas | 78229 | United States |
| Clinical Research Site | Wichita Falls | Texas | 76309 | United States |
| Clinical Research Site | Bellevue | Washington | 98007 | United States |
| Clinical Research Site | Everett | Washington | 98201 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
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| ID | Title | Description |
|---|---|---|
| BG000 | AXS-05 | AXS-05: Oral tablets, taken twice daily for up to 12 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 (NIH/OMB) | Count of Participants | Participants |
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| 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 | Types and rates of adverse events | Primary Safety Population (subjects who continued beyond Week 6 of the trial) | Posted | Count of Participants | Participants | Up to 12 months |
|
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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 study visit.
Overall Safety Population (all subjects who received at least 1 dose of AXS-05)
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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: Oral tablets, taken twice daily for up to 12 months. | 2 | 876 | 21 | 876 | 609 | 876 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Dictionary | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Dictionary | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Dictionary | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Dictionary | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Dictionary | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Dictionary | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Peripheral artery occlusion | Vascular disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Dictionary | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Dictionary | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
|
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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 |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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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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