Axsome Therapeutics doses first patient in CLARITY Phase 3 trial of solriamfetol for MDD with excessive daytime sleepiness. Learn about this promising therapy for unmet needs.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Axsome Therapeutics, Inc., a biopharmaceutical leader in central nervous system (CNS) disorders, has reached a key milestone: the first patient has been dosed in the CLARITY Phase 3 trial evaluating solriamfetol for major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms.
The CLARITY trial short for Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol is a rigorous Phase 3 study. It’s designed as a double-blind, placebo-controlled, multicentre randomized withdrawal trial. Participants first enter an open-label period where everyone receives solriamfetol. Those who respond well (showing improvement) then get randomized 1:1 to either continue solriamfetol or switch to placebo. The primary endpoint measures time from randomization to relapse of depressive symptoms, capturing how well the drug prevents symptom return.
This trial addresses a critical unmet need. MDD affects over 21 million U.S. adults, ranking as a top cause of global disability. Beyond core symptoms like persistent low mood, loss of interest, sleep disturbances, and low energy, many patients about 50% also battle EDS. This excessive daytime sleepiness makes it hard to stay awake, even in unsafe or key moments, worsening daily function, cognitive issues, and relapse risk. No treatments are currently approved specifically for MDD with EDS, leaving patients without targeted options.
Solriamfetol, a novel dopamine/norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist, shows promise across sleep- and mood-related conditions. Axsome is developing it for ADHD, MDD with EDS, binge eating disorder (BED), and shift work disorder (SWD)-related sleepiness. By boosting key neurotransmitters and receptors involved in wakefulness and mood regulation, it could fill this gap.
If successful, CLARITY could pave the way for the first approved therapy tackling both depression and its debilitating sleepiness component, potentially transforming care for millions. Axsome plans to share topline results once the trial advances.
References
Axsome Therapeutics Initiates CLARITY Phase 3 Trial of Solriamfetol in Adults with Major Depressive Disorder with Excessive Daytime Sleepiness Symptoms, 24 February 2026, Axsome Therapeutics Initiates CLARITY Phase 3 Trial of Solriamfetol in Adults with Major Depressive Disorder with Excessive Daytime Sleepiness Symptoms | Axsome Therapeutics, Inc.
About Writer
Nitisha Jha 1 BPharm
She is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.