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

• Status: Completed
• Trial end date: 2019-12-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Dextromethorphan

Criteria

Key Inclusion Criteria:

• Age 18 - 65

• Currently meets DSM-5 criteria for MDD

• Body Mass Index between 18 and 40 kg/m^2, inclusive

Key Exclusion Criteria:

• Suicide risk

• History of treatment resistance in current depressive episode

• History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months

• Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study