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Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

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: NCT04634669
Recruitment Status : Completed
First Posted : November 18, 2020
Last Update Posted : June 6, 2022
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief Summary:
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD).

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Major Depressive Disorder Drug: AXS-05 (dextromethorphan-bupropion) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression
Actual Study Start Date : September 23, 2020
Actual Primary Completion Date : March 4, 2022
Actual Study Completion Date : March 4, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AXS-05 (dextromethorphan-bupropion) Drug: AXS-05 (dextromethorphan-bupropion)
- AXS-05 tablet, taken daily (up to 15 months)

Primary Outcome Measures :
  1. Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05 [ Time Frame: Up to 15 months ]

Other Outcome Measures:
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Up to 15 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Continued depression despite treatment with antidepressants in the current depressive episode
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Information from the National Library of Medicine

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): NCT04634669

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United States, Arkansas
Clinical Research Site
Little Rock, Arkansas, United States, 72209
United States, California
Clinical Research Site
Redlands, California, United States, 92374
Clinical Research Site
Sherman Oaks, California, United States, 91403
Clinical Research Site
Upland, California, United States, 91786
United States, Florida
Clinical Research Site
Miami, Florida, United States, 33122
Clinical Research Site
North Miami, Florida, United States, 33161
Clinical Research Site
Orlando, Florida, United States, 32081
United States, Illinois
Clinical Research Site
Chicago, Illinois, United States, 60634
United States, Massachusetts
Clinical Research Site
Boston, Massachusetts, United States, 02131
United States, New Jersey
Clinical Research Site
Berlin, New Jersey, United States, 08009
United States, New York
Clinical Research Site
Rochester, New York, United States, 14618
Clinical Research Site
Staten Island, New York, United States, 10312
United States, North Carolina
Clinical Research Site
Hickory, North Carolina, United States, 28601
Clinical Research Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Clinical Research Site
Cincinnati, Ohio, United States, 45215
Clinical Research Site
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Clinical Research Site
Media, Pennsylvania, United States, 19063
United States, Texas
Clinical Research Site
Dallas, Texas, United States, 75243
Clinical Research Site
Friendswood, Texas, United States, 77546
United States, Washington
Clinical Research Site
Everett, Washington, United States, 98201
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04634669    
Other Study ID Numbers: AXS-05-TRD-202
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Axsome Therapeutics, Inc.:
Treatment Resistant Depression
NMDA receptor
Refractory depression
Resistant depression
Major depression
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents