nctId: NCT06360419 id: SOL-MDD-301 briefTitle: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol acronym: PARADIGM overallStatus: RECRUITING date: 2024-03-18 date: 2025-12 date: 2025-12 date: 2024-04-11 date: 2024-04-11 name: Axsome Therapeutics, Inc. class: INDUSTRY briefSummary: 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. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Solriamfetol 300 mg name: Placebo measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Incidence of treatment-emergent adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Site status: RECRUITING city: Encino state: California zip: 91316 country: United States lat: 34.15917 lon: -118.50119 facility: Clinical Research Site status: RECRUITING city: Lemon Grove state: California zip: 91945 country: United States lat: 32.74255 lon: -117.03142 facility: Clinical Research Site status: RECRUITING city: Oceanside state: California zip: 92056 country: United States lat: 33.19587 lon: -117.37948 facility: Clinical Research Site status: RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Clinical Research Site status: RECRUITING city: Riverside state: California zip: 92506 country: United States lat: 33.95335 lon: -117.39616 facility: Clinical Research Site status: RECRUITING city: Sherman Oaks state: California zip: 91403 country: United States lat: 34.15112 lon: -118.44925 facility: Clinical Research Site status: RECRUITING city: Upland state: California zip: 91786 country: United States lat: 34.09751 lon: -117.64839 facility: Clinical Research Site status: RECRUITING city: Cromwell state: Connecticut zip: 06416 country: United States lat: 41.5951 lon: -72.64537 facility: Clinical Research Site status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Research Site status: RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32801 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Chicago state: Illinois zip: 60634 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Research Site status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States lat: 42.35843 lon: -71.05977 facility: Clinical Research Site status: RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Research Site status: RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States lat: 36.17497 lon: -115.13722 facility: Clinical Research Site status: RECRUITING city: Brooklyn state: New York zip: 11235 country: United States lat: 40.6501 lon: -73.94958 facility: Clinical Research Site status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Clinical Research Site status: RECRUITING city: Hickory state: North Carolina zip: 28601 country: United States lat: 35.73319 lon: -81.3412 facility: Clinical Research Site status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73118 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Research Site status: RECRUITING city: Media state: Pennsylvania zip: 19063 country: United States lat: 39.91678 lon: -75.38769 facility: Clinical Research Site status: RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 facility: Clinical Research Site status: RECRUITING city: Wichita Falls state: Texas zip: 76309 country: United States lat: 33.91371 lon: -98.49339 facility: Clinical Research Site status: RECRUITING city: Everett state: Washington zip: 98201 country: United States lat: 47.97898 lon: -122.20208 hasResults: False