The CLARITY trial utilizes a randomized withdrawal design to assess time to relapse of depressive symptoms in patients with major depressive disorder and excessive daytime sleepiness.
Key takeaways:
- Axsome Therapeutics has initiated the CLARITY Phase 3 trial for solriamfetol in treating MDD with EDS symptoms.
- The multicenter study features an open-label treatment phase followed by a double-blind, randomized withdrawal period.
- The primary endpoint focuses on the time from randomization to the relapse of depressive symptoms.
- EDS affects approximately 50% of patients with MDD, yet there are currently no approved treatments for this specific indication.
Axsome Therapeutics Inc has announced that the first patient has been dosed in the CLARITY phase 3 trial evaluating solriamfetol for the treatment of major depressive disorder with excessive daytime sleepiness symptoms.
CLARITY, which stands for Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol, is a double-blind, placebo-controlled, multicenter randomized withdrawal trial.
The study consists of an open-label solriamfetol treatment period followed by a randomized, double-blind treatment period. Patients who achieve a treatment response during the open-label phase will be randomized in a 1:1 ratio to either continue solriamfetol or switch to a placebo.
The primary endpoint of the trial is the time from randomization to the relapse of depressive symptoms.
Excessive daytime sleepiness is a common symptom in individuals with major depressive disorder, affecting approximately 50% of patients. It is associated with a greater risk of major depressive episodes. Patients with EDS experience difficulty maintaining wakefulness and an increased tendency to fall asleep during the day, which can result in impaired daily functioning and safety risks.
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor, TAAR1 agonist, and 5-HT1A agonist. In addition to major depressive disorder with excessive daytime sleepiness, the drug is being investigated for the treatment of attention deficit hyperactivity disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder. It’s FDA-approved to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
