Axsome Therapeutics Doses First Patient in CLARITY Phase 3 Trial for Major Depressive Disorder with Excessive Daytime Sleepiness
Axsome Therapeutics has dosed the first patient in its CLARITY Phase 3 double-blind, placebo-controlled randomized withdrawal trial of solriamfetol for major depressive disorder patients with excessive daytime sleepiness. The trial’s primary endpoint measures time to relapse of depressive symptoms following an open-label treatment period and 1:1 randomization against placebo.
1. Trial Initiation
Axsome has dosed the first patient in its CLARITY Phase 3 trial of solriamfetol for major depressive disorder patients with excessive daytime sleepiness, marking the company’s entry into this new indication for its dopamine and norepinephrine reuptake inhibitor.
2. Trial Design
CLARITY is a multicenter, double-blind, placebo-controlled randomized withdrawal study featuring an open-label solriamfetol lead-in period; patients achieving a treatment response will be randomized 1:1 to continue active treatment or switch to placebo, with time to relapse of depressive symptoms as the primary endpoint.
3. Unmet Need and Drug Profile
Excessive daytime sleepiness affects 50% of adults with major depressive disorder and carries increased risk of recurrent episodes, with no therapies currently approved for this symptom; solriamfetol’s profile as a DNRI, TAAR1 agonist and 5-HT1A agonist supports its investigation across psychiatric and sleep-related conditions.