Overview
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.
Description
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.
Eligibility
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