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