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Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Exploring Solriamfetol effects for Shift Work Disorder.

Recruiting
18-65 years
All
Phase 3
Shift Work Disorder Study

Shift Work Disorder (SWD) is when people have trouble sleeping because they work at night or have different work shifts. This study is testing a medicine called Solriamfetol to see if it can help adults with SWD feel less tired. The study is randomized (participants are randomly chosen for different groups), double-blind (neither the participants nor the researchers know who gets the real medicine or a pretend one called a placebo), and will last for 12 weeks.

Participants will either get Solriamfetol in doses of 150 mg, 300 mg, or a placebo. To join, you must be between 18 and 65 years old and meet certain sleep disorder criteria. You can't join if you've already tried Solriamfetol or if you can't follow the study rules.

  • The study lasts for 12 weeks with one dose per night shift.
  • Participants will be randomly assigned to different groups.
  • Safety and effectiveness of the medicine will be checked.
Study details
    Excessive Sleepiness
    Shift-work Disorder

NCT06568367

Axsome Therapeutics, Inc.

30 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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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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