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

Evaluating Solriamfetol for treating depression with daytime sleepiness.

Recruiting
18-65 years
All
Phase 3

This study is focused on patients with major depressive disorder (MDD), a condition that leads to persistent feelings of sadness, and excessive daytime sleepiness (EDS), meaning they feel very sleepy during the day. The study tests a medicine called solriamfetol to see if it helps. It involves several stages: a screening period to see if you qualify, an open-label period where everyone gets solriamfetol, and a double-blind randomized withdrawal period where you might either continue with solriamfetol or receive a placebo (a pill with no active medicine) without knowing which you are getting. This helps scientists see if solriamfetol really works. You must be between 18 and 65 years old, meet the criteria for MDD, and be able to follow study procedures.

  • The study involves multiple visits and lasts several weeks.
  • Participants may receive a placebo, which looks like the real medicine but has no active ingredient.
  • It's important to check if you have any other health conditions, as some may exclude you from participating.
Study details
    Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

NCT07484217

Axsome Therapeutics, Inc.

10 October 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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