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A Trial of AXS-05 in Patients With Major Depressive Disorder (GEMINI)

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: NCT04019704
Recruitment Status : Completed
First Posted : July 15, 2019
Results First Posted : October 12, 2022
Last Update Posted : October 12, 2022
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
Conditions Depression
Major Depressive Disorder
Interventions Drug: AXS-05
Drug: Placebo
Enrollment 327
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AXS-05 Placebo
Hide Arm/Group Description

AXS-05 (bupropion and dextromethorphan) oral tablets

AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.

Placebo oral tablets to match AXS-05

Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

Period Title: Overall Study
Started 163 164
Completed 123 147
Not Completed 40 17
Arm/Group Title AXS-05 Placebo Total
Hide Arm/Group Description

AXS-05 (bupropion and dextromethorphan) oral tablets

AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.

Placebo oral tablets to match AXS-05

Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 163 164 327
Hide Baseline Analysis Population Description
Participants randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 164 participants 327 participants
42.1  (12.71) 41.1  (13.78) 41.6  (13.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 164 participants 327 participants
Female
98
  60.1%
117
  71.3%
215
  65.7%
Male
65
  39.9%
47
  28.7%
112
  34.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 164 participants 327 participants
American Indian or Alaska Native
1
   0.6%
1
   0.6%
2
   0.6%
Asian
9
   5.5%
8
   4.9%
17
   5.2%
Native Hawaiian or Other Pacific Islander
1
   0.6%
2
   1.2%
3
   0.9%
Black or African American
61
  37.4%
55
  33.5%
116
  35.5%
White
88
  54.0%
92
  56.1%
180
  55.0%
More than one race
3
   1.8%
3
   1.8%
6
   1.8%
Unknown or Not Reported
0
   0.0%
3
   1.8%
3
   0.9%
1.Primary Outcome
Title Change in MADRS Total Score From Baseline to Week 6
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) Population
Arm/Group Title AXS-05 Placebo
Hide Arm/Group Description:

AXS-05 (bupropion and dextromethorphan) oral tablets

AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.

Placebo oral tablets to match AXS-05

Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

Overall Number of Participants Analyzed 156 162
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
15.91  (0.921) 12.04  (0.862)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AXS-05, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description Safety Population
 
Arm/Group Title AXS-05 Placebo
Hide Arm/Group Description

AXS-05 (bupropion and dextromethorphan) oral tablets

AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.

Placebo oral tablets to match AXS-05

Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

All-Cause Mortality
AXS-05 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/162 (0.00%)      0/164 (0.00%)    
Hide Serious Adverse Events
AXS-05 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/162 (0.62%)      0/164 (0.00%)    
Gastrointestinal disorders     
Pancreatitis * 1 [1]  1/162 (0.62%)  1 0/164 (0.00%)  0
1
Term from vocabulary, MedDRA Dictionary
*
Indicates events were collected by non-systematic assessment
[1]
Not related to study drug.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AXS-05 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/162 (61.73%)      74/164 (45.12%)    
Gastrointestinal disorders     
Nausea * 1  21/162 (12.96%)  24 14/164 (8.54%)  14
Diarrhea * 1  11/162 (6.79%)  11 5/164 (3.05%)  5
Dry mouth * 1  9/162 (5.56%)  9 4/164 (2.44%)  4
General disorders     
All Others, occurring in <5% of Subjects * 1 [1]  47/162 (29.01%)  43/164 (26.22%) 
Nervous system disorders     
Dizziness * 1  26/162 (16.05%)  29 10/164 (6.10%)  12
Headache * 1  13/162 (8.02%)  16 6/164 (3.66%)  6
Somnolence * 1  11/162 (6.79%)  11 5/164 (3.05%)  5
1
Term from vocabulary, MedDRA Dictionary
*
Indicates events were collected by non-systematic assessment
[1]
All other events
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: Caroline Streicher, Senior Director, Clinical Operations
Organization: Axsome Therapeutics, Inc.
Phone: 212-332-5061
EMail: cstreicher@axsome.com
Layout table for additonal information
Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04019704    
Other Study ID Numbers: AXS-05-MDD-301
First Submitted: July 11, 2019
First Posted: July 15, 2019
Results First Submitted: September 16, 2022
Results First Posted: October 12, 2022
Last Update Posted: October 12, 2022