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

Primary Purpose

Treatment Resistant Depression, Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AXS-05 (dextromethorphan-bupropion)
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Dextromethorphan, Bupropion, MDD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features
  • 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

Sites / Locations

  • Clinical Research Site
  • Clinical Research Site
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  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXS-05 (dextromethorphan-bupropion)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
March 3, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04634669
Brief Title
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
Official Title
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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) and major depressive disorder (MDD).
Detailed Description
Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Major Depressive Disorder
Keywords
AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Dextromethorphan, Bupropion, MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-05 (dextromethorphan-bupropion)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AXS-05 (dextromethorphan-bupropion)
Intervention Description
- AXS-05 tablet, taken daily (up to 15 months)
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05
Time Frame
Up to 15 months
Other Pre-specified Outcome Measures:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
Up to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features 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
Facility Information:
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Clinical Research Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Clinical Research Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Clinical Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Clinical Research Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Clinical Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Clinical Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Clinical Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Clinical Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Clinical Research Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Clinical Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Clinical Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Clinical Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Clinical Research Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Clinical Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Clinical Research Site
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Clinical Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

Learn more about this trial

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

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