PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.

Eligible subjects must have a primary diagnosis of MDD without psychotic features based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1 ratio to receive either solriamfetol (300 mg) or placebo for 6 weeks.

Inclusion Criteria:

• Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
• Current major depressive episode
• Male or female, aged 18 to 65 inclusive

Exclusion Criteria:

• Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
• Unable to comply with study procedures
• Medically inappropriate for study participation in the opinion of the investigator