As reported by The Manila Times, Axsome Therapeutics has announced the initiation of its Phase 3 CLARITY clinical trial evaluating solriamfetol as a potential treatment for adults with major depressive disorder (MDD) who experience excessive daytime sleepiness (EDS), an often-overlooked symptom that can significantly affect daily functioning. The company reported that the first participant has now been enrolled and dosed in the study.
The CLARITY trial, short for Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol, is designed as a multicenter, randomized, double-blind, placebo-controlled withdrawal study. The trial begins with an open-label treatment phase in which all participants receive solriamfetol. Patients who demonstrate a positive response during this period will then be randomly assigned to either continue treatment with solriamfetol or transition to placebo in a double-blind phase.
Researchers will primarily evaluate the length of time between randomization and the return of depressive symptoms, a measure intended to assess whether continued treatment helps maintain clinical benefit.
Significant Unmet Need in Depression
Major depressive disorder remains one of the most prevalent psychiatric illnesses worldwide and is a leading contributor to disability. More than 21 million adults in the United States are affected by the condition, which is characterized by persistent low mood, diminished interest in activities, sleep and appetite disturbances, cognitive difficulties, fatigue, and feelings of guilt or worthlessness. In severe cases, MDD can increase the risk of suicide.
Excessive daytime sleepiness is reported in roughly half of individuals with depression and has been linked to a higher likelihood of depressive episodes. Patients with EDS struggle to stay alert during the day and may experience unintended sleep episodes, affecting work performance, social functioning, and overall quality of life. The symptom can also create safety concerns, particularly during activities that require sustained attention.
Despite its prevalence, there are currently no therapies specifically approved to treat excessive daytime sleepiness in people with major depressive disorder.
About Solriamfetol
Solriamfetol is a neuroscience-focused investigational therapy that acts through multiple mechanisms, including inhibition of dopamine and norepinephrine reuptake. It also exhibits activity as a trace amine-associated receptor 1 (TAAR1) agonist and a 5-HT1A receptor agonist.
Axsome is studying the compound across a range of neuropsychiatric and sleep-related conditions, including attention-deficit/hyperactivity disorder (ADHD), binge eating disorder (BED), excessive sleepiness associated with shift work disorder (SWD), and MDD accompanied by excessive daytime sleepiness.
The launch of the CLARITY trial marks an important step in evaluating whether solriamfetol can address both depressive symptoms and the debilitating daytime sleepiness experienced by many patients with major depressive disorder, an area where treatment options remain limited.
