Open-Label Safety Study of AXS-05 in Subjects With Depression
|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: NCT04039022|
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Treatment Resistant Depression Depression||Drug: AXS-05||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||876 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder|
|Actual Study Start Date :||July 8, 2019|
|Actual Primary Completion Date :||October 23, 2020|
|Actual Study Completion Date :||October 23, 2020|
|Experimental: AXS-05 (dextromethorphan and bupropion)||
Oral tablets, taken twice daily for up to 12 months.
- Types and rates of adverse events [ Time Frame: Up to 12 months ]Safety
- Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Up to 12 months ]The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039022