Assessing Symptomatic Clinical Episodes in Depression

A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Inclusion Criteria:

• Currently meets DSM-5 criteria for MDD
• Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
• Agree to use adequate method of contraception for the duration of the study
• Additional criteria may apply

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
• Additional criteria may apply