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

An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04634669

Enrollment

181

Registered

2020-11-18

Start date

2020-09-23

Completion date

2022-03-04

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Treatment Resistant Depression

Keywords

AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Dextromethorphan, Bupropion, MDD

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

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.

Interventions

DRUGAXS-05 (dextromethorphan-bupropion)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Baseline characteristics

Characteristic	—
Age, Continuous	46.6 years STANDARD_DEVIATION 13.1
Race/Ethnicity, Customized Asian	3 Participants
Race/Ethnicity, Customized Black or African American	29 Participants
Race/Ethnicity, Customized Multiple	2 Participants
Race/Ethnicity, Customized Other	3 Participants
Race/Ethnicity, Customized White	144 Participants
Sex: Female, Male Female	113 Participants
Sex: Female, Male Male	68 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 181
other Total, other adverse events	38 / 181
serious Total, serious adverse events	7 / 181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026