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Solriamfetol for major depression with excessive daytime sleepiness

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

Phase 3 Interventional Axsome Therapeutics, Inc. · NCT07484217

This trial will try solriamfetol (Sunosi) to reduce excessive daytime sleepiness in adults with major depressive disorder.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment508 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAxsome Therapeutics, Inc. Industry-sponsored
Locations13 sites (Chino, California and 12 other locations)
Trial IDNCT07484217 on ClinicalTrials.gov

What this trial studies

This Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial uses an open-label solriamfetol lead-in followed by a randomized withdrawal period. Eligible adults with MDD and excessive daytime sleepiness receive open-label solriamfetol (150 mg) and those who achieve a clinical response are randomized 1:1 to continue solriamfetol or switch to placebo. Participants are monitored during the double-blind period for relapse of depressive symptoms and for durability of wakefulness and safety effects. The protocol includes screening and follow-up periods and is conducted at clinical research sites in California.

Who should consider this trial

Good fit: Adults aged 18 to 65 with DSM-5 major depressive disorder without psychotic features who report excessive daytime sleepiness, can comply with study visits, and do not have other significant medical or sleep disorders are the intended participants.

Not a fit: People with other clinically significant medical, behavioral, or sleep disorders such as obstructive sleep apnea or narcolepsy, or those with psychotic features, are excluded and unlikely to benefit from this specific approach.

Why it matters

Potential benefit: If successful, solriamfetol could lessen daytime sleepiness and help maintain improvement in people with MDD who experience EDS.

How similar studies have performed: Solriamfetol is approved for treating excessive daytime sleepiness in narcolepsy and obstructive sleep apnea, but using it specifically for EDS linked to major depressive disorder is relatively novel with limited randomized evidence to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Chino, California and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Depressive Disorder With Excessive Daytime Sleepiness SymptomsSolriamfetolSunosiMajor Depressive Disorder with excessive daytime sleepinessMajor Depressive DisorderMDDAxsomeNon-stimulant therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.