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Open-Label Safety Study of AXS-05 in Subjects With Depression

Primary Purpose

Major Depressive Disorder, Treatment Resistant Depression, Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AXS-05 (dextromethorphan and bupropion) oral tablets
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, AXS-05, Dextromethorphan, Bupropion, Dopamine Reuptake Inhibitor, NMDA Receptor Antagonist, Nicotinic Acetylcholine Receptor Antagonist, Serotonin Reuptake Inhibitor, Axsome Therapeutics, Norepinephrine Reuptake Inhibitor, Sigma-1 Receptor Agonist, Glutamate Modulator, Antidepressant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of major depressive disorder, including treatment resistant depression
  • Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Exclusion Criteria:

  • Suicide risk
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Additional criteria may apply

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXS-05

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
Types and rates of adverse events

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
September 16, 2022
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04039022
Brief Title
Open-Label Safety Study of AXS-05 in Subjects With Depression
Official Title
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
Detailed Description
A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Treatment Resistant Depression, Depression
Keywords
Depression, AXS-05, Dextromethorphan, Bupropion, Dopamine Reuptake Inhibitor, NMDA Receptor Antagonist, Nicotinic Acetylcholine Receptor Antagonist, Serotonin Reuptake Inhibitor, Axsome Therapeutics, Norepinephrine Reuptake Inhibitor, Sigma-1 Receptor Agonist, Glutamate Modulator, Antidepressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
876 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-05
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AXS-05 (dextromethorphan and bupropion) oral tablets
Intervention Description
Oral tablets, taken twice daily for up to 12 months.
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
Description
Types and rates of adverse events
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of major depressive disorder, including treatment resistant depression Body mass index (BMI) between 18 and 40 kg/m^2, inclusive Agree to use adequate method of contraception for the duration of the study Additional criteria may apply Exclusion Criteria: Suicide risk Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study Additional criteria may apply
Facility Information:
Facility Name
Clinical Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Clinical Research Site
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Clinical Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Clinical Research Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Clinical Research Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Clinical Research Site
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Clinical Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Research Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
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
San Diego
State/Province
California
ZIP/Postal Code
92103
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
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Clinical Research Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Clinical Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Clinical Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Research Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
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
32801
Country
United States
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Clinical Research Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
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
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
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
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Clinical Research Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Clinical Research Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
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
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Clinical Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
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
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Clinical Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Clinical Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Research Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Clinical Research Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
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

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Open-Label Safety Study of AXS-05 in Subjects With Depression

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