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NCT07484217 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms, sponsored by Axsome Therapeutics.

Recruiting
Registry status
Phase 3
Development phase
508
Enrollment target
13
Study locations

NCT07484217: Recruiting Phase 3 study of Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms, sponsored by Axsome Therapeutics.

NCT07484217 is a Phase 3 study of Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms that is actively recruiting participants, run by Axsome Therapeutics. The registered enrollment target is 508 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT07484217, a Phase 3 study of Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms, is actively recruiting participants, sponsored by Axsome Therapeutics.

RECRUITING
Registry status
Phase 3
Development phase
508 participants
Enrollment target
13
Study locations

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.

Interventions

  • DRUG Placebo
  • DRUG Solriamfetol 150 MG

Study Locations (13)

California

  • Clinical Research Site - Chino
  • Clinical Research Site - Redlands
  • Clinical Research Site - Walnut Creek

Florida

  • Clinical Research Site - Jacksonville
  • Clinical Research Site - Miami

New Jersey

  • Clinical Research Site - Cherry Hill
  • Clinical Research Site - Toms River

New York

  • Clinical Research Site - Brooklyn
  • Clinical Research Site - The Bronx

Ohio

  • Clinical Research Site - Cincinnati

Oregon

  • Clinical Research Site - Portland

Tennessee

  • Clinical Research Site - Memphis

Texas

  • Clinical Research Site - Dallas

Trial Details

FieldValue
Enrollment Target 508 participants
Start Date 2026-02-23
Est. Completion 2028-12
Phase Phase 3
Axsome Therapeutics

28 total trials

What NCT07484217 shows while recruiting

NCT07484217 is an interventional study that assigns participants to a tested intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).

The record links to 1 condition, with Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07484217 lists 13 locations in 8 states (California, Florida, New Jersey).

Frequently Asked Questions

What is clinical trial NCT07484217 about?

NCT07484217 is a clinical study titled "Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol". 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) symptom...

What is the current status of trial NCT07484217?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2026-02-23. Estimated completion is 2028-12.

What conditions does trial NCT07484217 study?

This clinical trial studies the following conditions: Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms.

What interventions are being tested in trial NCT07484217?

The interventions under investigation include: Placebo (DRUG), Solriamfetol 150 MG (DRUG).

Who is sponsoring clinical trial NCT07484217?

This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07484217 being conducted?

This trial has 13 study locations across California, Florida, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT07484217's enrollment target sits among peer trials

508 737th of 2000 higher than 1,263 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT07484217, the US trial registry maintained by the National Library of Medicine. NCT07484217 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.