NCT04634669

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression
• Major Depressive Disorder

Interventions

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

Timeline

• Start date: 2020-09-23
• Primary completion: 2022-02-18
• Completion: 2022-03-04
• First posted: 2020-11-18
• Last updated: 2026-01-28
• Results posted: 2026-01-28

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study