NCT04039022

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

An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 876 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder
• Treatment Resistant Depression
• Depression

Interventions

Type	Name	Description
DRUG	AXS-05 (dextromethorphan and bupropion) oral tablets	Oral tablets, taken twice daily for up to 12 months.

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-10-23
• Completion: 2020-10-23
• First posted: 2019-07-31
• Last updated: 2022-10-12
• Results posted: 2022-10-12

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study