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

(CLARITY Trial)

Recruiting at 12 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

508 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT

Excessive daytime sleepiness symptoms

Able to comply with study procedures

Exclusion Criteria

Any clinically significant medical condition (e.g., OSA, narcolepsy), behavioral, or psychiatric disorder, other than MDD with EDS symptoms

Unable to comply with study procedures

Medically inappropriate for study participation in the opinion of the investigator

What Are the Treatments Tested in This Trial?

Interventions

• Solriamfetol

How Is the Trial Designed?

Group I: Solriamfetol 150mg Experimental Treatment 1 Intervention

* In the open-label period; * In the randomized double-blind period (if applicable)

Group II: Placebo Placebo Group 1 Intervention

• In the randomized double-blind period (if applicable)

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+