Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT06360419
- Lead Sponsor
- Axsome Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 346
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Solriamfetol 300 mg Solriamfetol 300 mg Up to 6 weeks Placebo Placebo Up to 6 weeks
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events 6 weeks Montgomery-Åsberg Depression Rating Scale (MADRS) 6 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Everett, Washington, United States