Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder

Key Inclusion Criteria:

• Male and Female subjects between 18-65 years of age, with a primary diagnosis ofmajor depressive disorder and in a current major depressive episode.

• History of an inadequate response to at least 1 and no more than 3 antidepressanttreatments in the current major depressive episode.

Key Exclusion Criteria:

• Subjects who report an inadequate response to more than 3 antidepressant treatmentsin the current episode.

• Subjects with a lifetime history of schizophrenia spectrum or other psychoticdisorder, bipolar or related disorder, neurocognitive disorder, or personalitydisorder.

• Subjects with a current diagnosis of post-traumatic stress disorder, obsessivecompulsive disorder, panic disorder, or eating disorder (including anorexia nervosaor bulimia).

• Sexually active subjects, who could become pregnant, not agreeing to practice 2sponsor approved methods of birth control or remain abstinent during the trial andfor 30 days (females) or 90 days (males) after last dose of study drug.