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Assessing Symptomatic Clinical Episodes in Depression (ASCEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595579
Recruitment Status : Completed
First Posted : July 23, 2018
Results First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: AXS-05
Drug: Bupropion
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AXS-05 Bupropion
Hide Arm/Group Description AXS-05: AXS-05 taken twice daily for 6 weeks. Bupropion: Bupropion taken twice daily for 6 weeks.
Period Title: Overall Study
Started 48 49
mITT Population 43 37
Safety Population 48 48
Completed 38 35
Not Completed 10 14
Arm/Group Title AXS-05 Bupropion Total
Hide Arm/Group Description AXS-05: AXS-05 taken twice daily for 6 weeks. Bupropion: Bupropion taken twice daily for 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 48 49 97
Hide Baseline Analysis Population Description
Participants randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 49 participants 97 participants
38.8  (11.98) 39.9  (12.96) 39.1  (12.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
Female
28
  58.3%
32
  65.3%
60
  61.9%
Male
20
  41.7%
17
  34.7%
37
  38.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.1%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  31.3%
16
  32.7%
31
  32.0%
White
32
  66.7%
29
  59.2%
61
  62.9%
More than one race
0
   0.0%
4
   8.2%
4
   4.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title MADRS Score - Overall Change From Baseline
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) Population
Arm/Group Title AXS-05 Bupropion
Hide Arm/Group Description:
AXS-05: AXS-05 taken twice daily for 6 weeks.
Bupropion: Bupropion taken twice daily for 6 weeks.
Overall Number of Participants Analyzed 43 37
Mean (Standard Error)
Unit of Measure: score on a scale
13.7  (0.63) 8.8  (0.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AXS-05, Bupropion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Other Pre-specified Outcome
Title MADRS Score - Change From Baseline to Week 6
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) Population
Arm/Group Title AXS-05 Bupropion
Hide Arm/Group Description:
AXS-05: AXS-05 taken twice daily for 6 weeks.
Bupropion: Bupropion taken twice daily for 6 weeks.
Overall Number of Participants Analyzed 43 37
Mean (Standard Error)
Unit of Measure: score on a scale
17.2  (1.4) 12.1  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AXS-05, Bupropion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description Safety Population
 
Arm/Group Title AXS-05 Bupropion
Hide Arm/Group Description AXS-05: AXS-05 taken twice daily for 6 weeks. Bupropion: Bupropion taken twice daily for 6 weeks.
All-Cause Mortality
AXS-05 Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Hide Serious Adverse Events
AXS-05 Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AXS-05 Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   35/48 (72.92%)   30/48 (62.50%) 
Gastrointestinal disorders     
Constipation * 1  3/48 (6.25%)  4/48 (8.33%) 
Diarrhea * 1  3/48 (6.25%)  4/48 (8.33%) 
Dry mouth * 1  5/48 (10.42%)  4/48 (8.33%) 
Nausea * 1  8/48 (16.67%)  6/48 (12.50%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  5/48 (10.42%)  4/48 (8.33%) 
Nervous system disorders     
Dizziness * 1  10/48 (20.83%)  2/48 (4.17%) 
Headache * 1  4/48 (8.33%)  5/48 (10.42%) 
Sedation * 1  3/48 (6.25%)  0/48 (0.00%) 
Tension headache * 1  3/48 (6.25%)  2/48 (4.17%) 
Psychiatric disorders     
Anxiety * 1  5/48 (10.42%)  1/48 (2.08%) 
Insomnia * 1  4/48 (8.33%)  2/48 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Yawning * 1  3/48 (6.25%)  0/48 (0.00%) 
1
Term from vocabulary, MedDRA Dictionary
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amanda Jones, PharmD, Senior Vice President of Clinical Development
Organization: Axsome Therapeutics, Inc.
Phone: 212-332-3223
EMail: ajones@axsome.com
Layout table for additonal information
Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03595579    
Other Study ID Numbers: AXS-05-MDD-201
First Submitted: June 20, 2018
First Posted: July 23, 2018
Results First Submitted: July 30, 2021
Results First Posted: September 24, 2021
Last Update Posted: September 24, 2021