Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
NCT ID: NCT06568367
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
520 participants
INTERVENTIONAL
2024-08-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Solriamfetol 150mg
Up to 12 weeks
Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Solriamfetol 300mg
Up to 12 weeks
Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo
Up to 12 weeks
Placebo
Placebo tablets, taken once daily
Interventions
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Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo
Placebo tablets, taken once daily
Eligibility Criteria
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Inclusion Criteria
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 65 inclusive.
Exclusion Criteria
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Cullman, Alabama, United States
Clinical Research Site
Chandler, Arizona, United States
Clinical Research Site
Tucson, Arizona, United States
Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Cerritos, California, United States
Clinical Research Site
Chula Vista, California, United States
Clinical Research Site
Huntington Beach, California, United States
Clinical Research Site
Long Beach, California, United States
Clinical Research Site
Santa Ana, California, United States
Clinical Research Site
Colorado Springs, Colorado, United States
Clinical Research Site
Brandon, Florida, United States
Clinical Research Site
Hialeah, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami Lakes, Florida, United States
Clinical Research Site
Atlanta, Georgia, United States
Clinical Research Site
Stockbridge, Georgia, United States
Clinical Research Site
Towson, Maryland, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Lansing, Michigan, United States
Clinical Research Site
Novi, Michigan, United States
Clinical Research Site
Southfield, Michigan, United States
Clinical Research Site
Chesterfield, Missouri, United States
Clinical Research Site
St Louis, Missouri, United States
Clinical Research Site
Henderson, Nevada, United States
Clinical Research Site
Middletown, New Jersey, United States
Clinical Research Site
Denver, North Carolina, United States
Clinical Research Site
Fayetteville, North Carolina, United States
Clinical Research Site
Huntersville, North Carolina, United States
Clinical Research Site
Cincinnati, Ohio, United States
Clinical Research Site
Cincinnati, Ohio, United States
Clinical Research Site
Wyomissing, Pennsylvania, United States
Clinical Research Site
Charleston, South Carolina, United States
Clinical Research Site
Columbia, South Carolina, United States
Clinical Research Site
Houston, Texas, United States
Clinical Research Site
San Antonio, Texas, United States
Clinical Research Site
Sugar Land, Texas, United States
Clinical Research Site
Markham, Ontario, Canada
Clinical Research Site
Toronto, Ontario, Canada
Countries
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Central Contacts
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Related Links
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SUSTAIN Study Website
Axsome Therapeutics Website
Other Identifiers
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SOL-SWD-301
Identifier Type: -
Identifier Source: org_study_id
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