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RecruitingNCT07484217

Solriamfetol for daytime sleepiness with depression

About this titleRead the official source — NCT07484217
Medication studyAges 18–65United States
The study in practice

Understand this study

Who could participate?

This study is for people with depression. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.

What will I do during this study?

This study has an open-label solriamfetol treatment period followed by a randomized withdrawal phase for participants who respond. Responders are assigned to continue solriamfetol or switch to placebo (an inactive comparison treatment); screening and follow-up assessments are also part of the study.

Listed locations
Tucson and 39 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.

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What to know before participating

A point to clarify

This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?

Study clarity

Things to check before joining

Study start dateStarted: February 23, 2026
Recruitment status
Recruiting
Enrollment listed in the registry
508
Sponsor
Axsome Therapeutics, Inc.
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States
Age range
From 18 Years to 65 Years
Official registry ID
NCT07484217
Official title
Show the full official title

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Recruitment & locations

Currently recruiting

Tucson · Bellflower · Chino

33 more locations
  • Glendale
  • Imperial
  • Los Angeles
  • Oceanside
  • Redlands
  • San Diego
  • Sherman Oaks
  • Walnut Creek
  • Jacksonville
  • Miami
  • Atlanta
  • Norcross
  • Snellville
  • Chicago
  • Pikesville
  • Springfield
  • Las Vegas
  • Cherry Hill
  • Toms River
  • Brooklyn
  • New York
  • Staten Island
  • The Bronx
  • Cincinnati
  • Edmond
  • Oklahoma City
  • Portland
  • Memphis
  • Austin
  • Bellaire
  • Dallas
  • Houston
  • San Antonio

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FAQ

Questions about this study

Who is behind this study?

The study sponsor is Axsome Therapeutics, Inc.

Does this study involve medication?

Yes. The study involves medication, including Solriamfetol 150 MG and Placebo.

Who can participate?

This study is for people with depression. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.

Is this study still recruiting?

The registry lists this study as recruiting.

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