Major Depressive Disorder
Conditions
Keywords
AXS-05, Major Depressive Disorder, MDD, Axsome, Depression, Dextromethorphan, Bupropion, Sigma-1, NDMA, ASCEND
Brief summary
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
Detailed description
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.
Interventions
DRUGAXS-05
AXS-05 taken twice daily for 6 weeks.
DRUGBupropion
Bupropion taken twice daily for 6 weeks.
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Currently meets DSM-5 criteria for MDD * Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive * Agree to use adequate method of contraception for the duration of the study * Additional criteria may apply
Exclusion criteria
* 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 * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS Score - Overall Change From Baseline | Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| MADRS Score - Change From Baseline to Week 6 | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AXS-05 AXS-05: AXS-05 taken twice daily for 6 weeks. | 48 |
| Bupropion Bupropion: Bupropion taken twice daily for 6 weeks. | 49 |
| Total | 97 |
Baseline characteristics
| Characteristic | Bupropion | Total | AXS-05 |
|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 12.96 | 39.1 years STANDARD_DEVIATION 12.34 | 38.8 years STANDARD_DEVIATION 11.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 31 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 61 Participants | 32 Participants |
| Sex: Female, Male Female | 32 Participants | 60 Participants | 28 Participants |
| Sex: Female, Male Male | 17 Participants | 37 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 35 / 48 | 30 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
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.
Time frame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)
Population: modified Intent-to-Treat (mITT) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXS-05 | MADRS Score - Overall Change From Baseline | 13.7 score on a scale | Standard Error 0.63 |
| Bupropion | MADRS Score - Overall Change From Baseline | 8.8 score on a scale | Standard Error 0.68 |
p-value: <0.001Mixed Models Analysis
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.
Time frame: 6 weeks
Population: modified Intent-to-Treat (mITT) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXS-05 | MADRS Score - Change From Baseline to Week 6 | 17.2 score on a scale | Standard Error 1.4 |
| Bupropion | MADRS Score - Change From Baseline to Week 6 | 12.1 score on a scale | Standard Error 1.5 |
p-value: 0.013Mixed Models Analysis