As published in Sleep Review Magazine, Axsome Therapeutics has officially begun dosing patients in its Phase 3 CLARITY trial, a study designed to evaluate solriamfetol as a potential treatment for major depressive disorder (MDD) accompanied by excessive daytime sleepiness (EDS), a symptom that affects roughly half of individuals with depression and currently lacks any approved therapeutic options.
A Novel Trial Design Targeting a Critical Unmet Need
The CLARITY study—Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol—uses a multicenter, randomized withdrawal design. All enrolled participants first receive solriamfetol during an open‑label treatment phase. Those who respond are then randomized to remain on solriamfetol or switch to placebo in a double‑blind phase.
The primary objective is to measure the time from randomization to the return of depressive symptoms, offering insight into solriamfetol’s ability to sustain therapeutic benefit in patients prone to EDS-related functional impairments.
Why Excessive Daytime Sleepiness Matters in MDD
Excessive daytime sleepiness is a common but often under-recognized feature of MDD. Individuals with EDS have difficulty staying awake and may unintentionally fall asleep during routine daytime activities. This symptom not only hinders daily functioning but is associated with a higher likelihood of recurrent depressive episodes, highlighting the need for targeted treatment options.
About Solriamfetol
Solriamfetol is a multifunctional agent that acts as a dopamine and norepinephrine reuptake inhibitor, while also exhibiting TAAR1 and 5‑HT1A agonist activity. It is already approved by the FDA to improve wakefulness in adults with EDS related to narcolepsy or obstructive sleep apnea.
Beyond the new MDD‑EDS indication, the drug is also in clinical development for attention‑deficit/hyperactivity disorder, binge eating disorder, and sleepiness associated with shift work disorder.
Looking Ahead
With the CLARITY trial now underway, Axsome aims to address a major gap in depression care by determining whether solriamfetol can reliably reduce relapse risk in patients whose depressive symptoms are complicated by persistent daytime sleepiness.
