Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT06360419
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Solriamfetol 300 mg — DRUG
    Solriamfetol tablets, taken once daily
  • Placebo — DRUG
    Placebo tablets, taken once daily

Study Details

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.

Key Dates

Start date
Mar 18, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2024
Completion
Mar 26, 2025

Study Design

Enrollment
346 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Solriamfetol 300 mg
    Up to 6 weeks
  • Placebo Comparator: Placebo
    Up to 6 weeks

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]

Locations (40)

FacilityCityStateZIPSite coordinators
Clinical Research SiteLittle RockArkansas72211-
Clinical Research SiteBellflowerCalifornia90706-
Clinical Research SiteEncinoCalifornia91316-
Clinical Research SiteLemon GroveCalifornia91945-
Clinical Research SiteLos AngelesCalifornia90015-
Clinical Research SiteMontclairCalifornia91763-
Clinical Research SiteOceansideCalifornia92056-
Clinical Research SiteRedlandsCalifornia92374-
Clinical Research SiteRiversideCalifornia92506-
Clinical Research SiteSherman OaksCalifornia91403-
Clinical Research SiteTorranceCalifornia90501-
Clinical Research SiteUplandCalifornia91786-
Clinical Research SiteWalnut CreekCalifornia94596-
Clinical Research SiteCromwellConnecticut06416-
Clinical Research SiteBrandonFlorida33511-
Clinical Research SiteHialeahFlorida33012-
Clinical Research SiteJacksonvilleFlorida32256-
Clinical Research SiteOrlandoFlorida32801-
Clinical Research SiteOrlandoFlorida32806-
Clinical Research SiteOrlandoFlorida32807-
Clinical Research SiteChicagoIllinois60634-
Clinical Research SiteOverland ParkKansas66210-
Clinical Research SiteNew OrleansLouisiana70115-
Clinical Research SiteBostonMassachusetts02131-
Clinical Research SiteSaint CharlesMissouri63304-
Clinical Research SiteLas VegasNevada89102-
Clinical Research SiteBrooklynNew York11235-
Clinical Research SiteRochesterNew York14609-
Clinical Research SiteStaten IslandNew York10314-
Clinical Research SiteHickoryNorth Carolina28601-
Clinical Research SiteCincinnatiOhio45215-
Clinical Research SiteOklahoma CityOklahoma73116-
Clinical Research SiteMediaPennsylvania19063-
Clinical Research SitePhiladelphiaPennsylvania19104-
Clinical Research SiteMemphisTennessee38119-
Clinical Research SiteAustinTexas78737-
Clinical Research SiteDallasTexas75231-
Clinical Research SiteFriendswoodTexas77546-
Clinical Research SiteWichita FallsTexas76309-
Clinical Research SiteEverettWashington98201-

Find similar trials in Little Rock, AR

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Clinical Research Site· Little Rock, ARClinical Research Site· Bellflower, CAClinical Research Site· Encino, CAClinical Research Site· Lemon Grove, CAClinical Research Site· Los Angeles, CAClinical Research Site· Montclair, CA

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