Assessing Symptomatic Clinical Episodes in Depression
Assessing Symptomatic Clinical Episodes in Depression
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