Solriamfetol for major depression with excessive daytime sleepiness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Research Site
  Tucson, Arizona, United States Recruiting
• Clinical Research Site
  Bellflower, California, United States Recruiting
• Clinical Research Site
  Chino, California, United States Recruiting
• Clinical Research Site
  Glendale, California, United States Recruiting
• Clinical Research Site
  Imperial, California, United States Recruiting
• Clinical Research Site
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: sol-mdd-302@axsome.com
• Phone: 2123325061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.