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

NCT07484217 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Interventions

DRUG

Solriamfetol 150 MG

Solriamfetol tablets, taken once daily

DRUG

Placebo

Placebo tablets, taken once daily

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-23
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07484217 on ClinicalTrials.gov