Trial Outcomes & Findings for Assessing Symptomatic Clinical Episodes in Depression (NCT NCT03595579)
NCT ID: NCT03595579
Last Updated: 2021-09-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)
Results posted on
2021-09-24
Participant Flow
Participant milestones
| Measure |
AXS-05
AXS-05: AXS-05 taken twice daily for 6 weeks.
|
Bupropion
Bupropion: Bupropion taken twice daily for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
49
|
|
Overall Study
mITT Population
|
43
|
37
|
|
Overall Study
Safety Population
|
48
|
48
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
10
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Symptomatic Clinical Episodes in Depression
Baseline characteristics by cohort
| Measure |
AXS-05
n=48 Participants
AXS-05: AXS-05 taken twice daily for 6 weeks.
|
Bupropion
n=49 Participants
Bupropion: Bupropion taken twice daily for 6 weeks.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 12.96 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
AXS-05
n=43 Participants
AXS-05: AXS-05 taken twice daily for 6 weeks.
|
Bupropion
n=37 Participants
Bupropion: Bupropion taken twice daily for 6 weeks.
|
|---|---|---|
|
MADRS Score - Overall Change From Baseline
|
13.7 score on a scale
Standard Error 0.63
|
8.8 score on a scale
Standard Error 0.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: modified Intent-to-Treat (mITT) Population
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.
Outcome measures
| Measure |
AXS-05
n=43 Participants
AXS-05: AXS-05 taken twice daily for 6 weeks.
|
Bupropion
n=37 Participants
Bupropion: Bupropion taken twice daily for 6 weeks.
|
|---|---|---|
|
MADRS Score - Change From Baseline to Week 6
|
17.2 score on a scale
Standard Error 1.4
|
12.1 score on a scale
Standard Error 1.5
|
Adverse Events
AXS-05
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Bupropion
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AXS-05
n=48 participants at risk
AXS-05: AXS-05 taken twice daily for 6 weeks.
|
Bupropion
n=48 participants at risk
Bupropion: Bupropion taken twice daily for 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.2%
3/48 • 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
|
8.3%
4/48 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
3/48 • 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
|
8.3%
4/48 • 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
|
|
Gastrointestinal disorders
Dry mouth
|
10.4%
5/48 • 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
|
8.3%
4/48 • 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
|
|
Gastrointestinal disorders
Nausea
|
16.7%
8/48 • 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
|
12.5%
6/48 • 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
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.4%
5/48 • 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
|
8.3%
4/48 • 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
|
|
Nervous system disorders
Dizziness
|
20.8%
10/48 • 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
|
4.2%
2/48 • 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
|
|
Nervous system disorders
Headache
|
8.3%
4/48 • 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
|
10.4%
5/48 • 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
|
|
Nervous system disorders
Sedation
|
6.2%
3/48 • 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
|
0.00%
0/48 • 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
|
|
Nervous system disorders
Tension headache
|
6.2%
3/48 • 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
|
4.2%
2/48 • 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
|
|
Psychiatric disorders
Anxiety
|
10.4%
5/48 • 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
|
2.1%
1/48 • 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
|
|
Psychiatric disorders
Insomnia
|
8.3%
4/48 • 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
|
4.2%
2/48 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
6.2%
3/48 • 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
|
0.00%
0/48 • 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
|
Additional Information
Amanda Jones, PharmD, Senior Vice President of Clinical Development
Axsome Therapeutics, Inc.
Phone: 212-332-3223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place