Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Solriamfetol 150 MG
DrugSolriamfetol tablets, taken once daily
Placebo
DrugPlacebo tablets, taken once daily
Treatment groups
508 Participants
are divided into 2 treatment groupsGroup A: Solriamfetol 150mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time from randomization to relapse of depressive symptoms
Time frame
Up to 24 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov