Major Depressive Disorder
Conditions
Keywords
Solriamfetol, Sunosi, MDD, Major Depressive Disorder, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
Brief summary
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.
Detailed 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.
Interventions
Solriamfetol tablets, taken once daily
DRUGPlacebo
Placebo tablets, taken once daily
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 6 weeks |
| Incidence of treatment-emergent adverse events | 6 weeks |
Countries
United States
Outcome results
None listed