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Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-05 | Experimental |
| |
| Bupropion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-05 | Drug | AXS-05 taken twice daily for 6 weeks. |
| |
| Bupropion |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS Score - Overall Change From Baseline | The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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. | Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period) |
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| Measure | Description | Time Frame |
|---|---|---|
| MADRS Score - Change From Baseline to Week 6 | The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Beverly Hills | California | 90210 | United States | ||
| Clinical Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35582785 | Derived | Tabuteau H, Jones A, Anderson A, Jacobson M, Iosifescu DV. Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. Epub 2022 May 18. |
| Label | URL |
|---|---|
| Related Info | View source |
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via publication
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| ID | Title | Description |
|---|---|---|
| FG000 | AXS-05 | AXS-05: AXS-05 taken twice daily for 6 weeks. |
| FG001 | Bupropion | Bupropion: Bupropion taken twice daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | AXS-05 | AXS-05: AXS-05 taken twice daily for 6 weeks. |
| BG001 | Bupropion | Bupropion: Bupropion taken twice daily for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | MADRS Score - Overall Change From Baseline | The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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 | Mean | Standard Error | score on a scale | Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period) |
|
Adverse events were collected from the time of signing the ICF through 30 days after the last study visit or Early Termination (ET), whichever occurred first, an average of 11 weeks per participant.
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: AXS-05 taken twice daily for 6 weeks. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Jones, PharmD, Senior Vice President of Clinical Development | Axsome Therapeutics, Inc. | 212-332-3223 | ajones@axsome.com |
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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 | Jun 28, 2018 | Jul 30, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2018 | Jul 30, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Drug |
Bupropion taken twice daily for 6 weeks. |
|
| 6 weeks |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Clinical Research Site | Orlando | Florida | 32801 | United States |
| Clinical Research Site | Bellevue | Washington | 98007 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Bupropion: Bupropion taken twice daily for 6 weeks. |
|
|
|
| Other Pre-specified | MADRS Score - Change From Baseline to Week 6 | The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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 | Mean | Standard Error | score on a scale | 6 weeks |
|
|
|
|
| 48 |
| 0 |
| 48 |
| 35 |
| 48 |
| EG001 | Bupropion | Bupropion: Bupropion taken twice daily for 6 weeks. | 0 | 48 | 0 | 48 | 30 | 48 |
| Diarrhea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Dictionary | Non-systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA Dictionary | Non-systematic Assessment |
|
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| D001519 |
| Behavior |