NCT04634669

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 major depressive disorder with prior treatment failures

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

November 12, 2020

Results QC Date

March 3, 2025

Last Update Submit

January 12, 2026

Conditions

Treatment Resistant DepressionMajor Depressive Disorder

Keywords

AXS-05Treatment Resistant DepressionTRDNMDA receptorRefractory depressionResistant depressionDepressionMajor depressionDextromethorphanBupropionMDD

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05

    Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date.

Study Arms (1)

AXS-05 (dextromethorphan-bupropion)

EXPERIMENTAL
Drug: AXS-05 (dextromethorphan-bupropion)

Interventions

AXS-05 (dextromethorphan-bupropion)DRUG

\- Titrated to AXS-05 (45 mg dextromethorphan HBr / 105 mg bupropion HCl) twice daily (up to 15 months)

AXS-05 (dextromethorphan-bupropion)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features and with prior antidepressant treatment failure * Agree to use adequate method of contraception for the duration of the study * Additional criteria may apply

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (20)

Clinical Research Site

Little Rock, Arkansas, 72209, United States

Location

Clinical Research Site

Redlands, California, 92374, United States

Location

Clinical Research Site

Sherman Oaks, California, 91403, United States

Location

Clinical Research Site

Upland, California, 91786, United States

Location

Clinical Research Site

Miami, Florida, 33122, United States

Location

Clinical Research Site

Miami Lakes, Florida, 33016, United States

Location

Clinical Research Site

Orlando, Florida, 32081, United States

Location

Clinical Research Site

Chicago, Illinois, 60634, United States

Location

Clinical Research Site

Boston, Massachusetts, 02131, United States

Location

Clinical Research Site

Berlin, New Jersey, 08009, United States

Location

Clinical Research Site

Rochester, New York, 14618, United States

Location

Clinical Research Site

Staten Island, New York, 10312, United States

Location

Clinical Research Site

Hickory, North Carolina, 28601, United States

Location

Clinical Research Site

Raleigh, North Carolina, 27609, United States

Location

Clinical Research Site

Cincinnati, Ohio, 45215, United States

Location

Clinical Research Site

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Research Site

Media, Pennsylvania, 19063, United States

Location

Clinical Research Site

Dallas, Texas, 75243, United States

Location

Clinical Research Site

Friendswood, Texas, 77546, United States

Location

Clinical Research Site

Everett, Washington, 98201, United States

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Caroline Streicher, Senior Vice President, Clinical Research
Organization
Axsome Therapeutics, Inc
cstreicher@axsome.com
212-332-5061

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

September 23, 2020

Primary Completion

February 18, 2022

Study Completion

March 4, 2022

Last Updated

January 28, 2026

Results First Posted

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(20)