NCT07484217

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period.

Detailed description

The study will consist of a screening period, an open label solriamfetol treatment period, a double-blind randomized withdrawal period, and a follow-up period. Eligible subjects will be treated with open-label solriamfetol and monitored for clinical response. Subjects achieving clinical response will be randomized into the double-blind randomized withdrawal period in a 1:1 ratio to either continued treatment with solriamfetol or to switch to placebo, for the remainder of the double-blind period or until they experience relapse of depressive symptoms.

Conditions

• Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Interventions

Type	Name	Description
DRUG	Solriamfetol 150 MG	Solriamfetol tablets, taken once daily
DRUG	Placebo	Placebo tablets, taken once daily

Timeline

• Start date: 2026-02-23
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study