NCT04019704

A Trial of AXS-05 in Patients With Major Depressive Disorder

AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Detailed description

This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Conditions

• Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	AXS-05	Oral AXS-05 tablets, taken daily for 6 weeks.
DRUG	Placebo	Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

Timeline

• Start date: 2019-06-20
• Primary completion: 2019-11-26
• Completion: 2019-12-05
• First posted: 2019-07-15
• Last updated: 2022-10-12
• Results posted: 2022-10-12

Locations

43 sites across 1 country: United States

Regulatory

• FDA-regulated drug study