Trial Outcomes & Findings for A Trial of AXS-05 in Patients With Major Depressive Disorder (NCT NCT04019704)
NCT ID: NCT04019704
Last Updated: 2022-10-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
327 participants
Primary outcome timeframe
6 weeks
Results posted on
2022-10-12
Participant Flow
Participant milestones
| Measure |
AXS-05
AXS-05 (bupropion and dextromethorphan) oral tablets
AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.
|
Placebo
Placebo oral tablets to match AXS-05
Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
164
|
|
Overall Study
COMPLETED
|
123
|
147
|
|
Overall Study
NOT COMPLETED
|
40
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of AXS-05 in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
AXS-05
n=163 Participants
AXS-05 (bupropion and dextromethorphan) oral tablets
AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.
|
Placebo
n=164 Participants
Placebo oral tablets to match AXS-05
Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 13.78 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: modified Intent-to-Treat (mITT) Population
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.
Outcome measures
| Measure |
AXS-05
n=156 Participants
AXS-05 (bupropion and dextromethorphan) oral tablets
AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.
|
Placebo
n=162 Participants
Placebo oral tablets to match AXS-05
Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
|
|---|---|---|
|
Change in MADRS Total Score From Baseline to Week 6
|
15.91 score on a scale
Standard Error 0.921
|
12.04 score on a scale
Standard Error 0.862
|
Adverse Events
AXS-05
Serious events: 1 serious events
Other events: 100 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AXS-05
n=162 participants at risk
AXS-05 (bupropion and dextromethorphan) oral tablets
AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.
|
Placebo
n=164 participants at risk
Placebo oral tablets to match AXS-05
Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.62%
1/162 • Number of events 1 • 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
|
0.00%
0/164 • 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
|
Other adverse events
| Measure |
AXS-05
n=162 participants at risk
AXS-05 (bupropion and dextromethorphan) oral tablets
AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.
|
Placebo
n=164 participants at risk
Placebo oral tablets to match AXS-05
Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
16.0%
26/162 • Number of events 29 • 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
|
6.1%
10/164 • Number of events 12 • 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
|
|
Gastrointestinal disorders
Nausea
|
13.0%
21/162 • Number of events 24 • 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
|
8.5%
14/164 • Number of events 14 • 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
|
|
Nervous system disorders
Headache
|
8.0%
13/162 • Number of events 16 • 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
|
3.7%
6/164 • Number of events 6 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
11/162 • Number of events 11 • 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
|
3.0%
5/164 • Number of events 5 • 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
|
|
Nervous system disorders
Somnolence
|
6.8%
11/162 • Number of events 11 • 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
|
3.0%
5/164 • Number of events 5 • 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
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
9/162 • Number of events 9 • 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
|
2.4%
4/164 • Number of events 4 • 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
|
|
General disorders
All Others, occurring in <5% of Subjects
|
29.0%
47/162 • 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
|
26.2%
43/164 • 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
|
Additional Information
Caroline Streicher, Senior Director, Clinical Operations
Axsome Therapeutics, Inc.
Phone: 212-332-5061
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place