Health Trials

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

ConditionMajor Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.

About 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.

Eligibility criteria

Qualifiers

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

Male or female, aged 18 to 65 years inclusive

Disqualifiers

Any clinically significant medical (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

Trial design

Treatments tested in this trial

  • Solriamfetol 150 MG
  • Placebo

Treatment groups

508 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Axsome Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov