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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
346
Solriamfetol tablets, taken once daily
Placebo tablets, taken once daily
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
Incidence of treatment-emergent adverse events
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Bellflower, California, United States
Clinical Research Site
Encino, California, United States
Clinical Research Site
Lemon Grove, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Montclair, California, United States
Clinical Research Site
Oceanside, California, United States
Clinical Research Site
Redlands, California, United States
Clinical Research Site
Riverside, California, United States
Clinical Research Site
Sherman Oaks, California, United States
...and 30 more locations