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

NCT04634669 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2026-01-28

Study results available
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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

Conditions

Interventions

DRUG

AXS-05 (dextromethorphan-bupropion)

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

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2022-02-18
Completion
2022-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634669 on ClinicalTrials.gov