Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 13, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07484217). This is a study registration, not published results. Lead sponsor: Axsome Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 508 participants (ESTIMATED). Conditions: Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms. Interventions: DRUG: Solriamfetol 150 MG; DRUG: Placebo. Primary outcome measures: Time from randomization to relapse of depressive symptoms , Up to 24 weeks.. Brief summary: CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period.