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

NCT07484217 · Axsome Therapeutics, Inc.
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Official title
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
About this study
The study will consist of a screening period, an open label solriamfetol treatment period, a double-blind randomized withdrawal period, and a follow-up period. Eligible subjects will be treated with open-label solriamfetol and monitored for clinical response. Subjects achieving clinical response will be randomized into the double-blind randomized withdrawal period in a 1:1 ratio to either continued treatment with solriamfetol or to switch to placebo, for the remainder of the double-blind period or until they experience relapse of depressive symptoms.
Eligibility 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
Study design
Enrollment target: 508 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-02-23
Estimated completion: 2028-12
Last updated: 2026-07-24
Interventions
Drug: Solriamfetol 150 MGDrug: Placebo
Primary outcomes
  • Time from randomization to relapse of depressive symptoms (Up to 24 weeks.)
Sponsor
Axsome Therapeutics, Inc. · industry
Contacts & investigators
ContactStudy Director · contact · sol-mdd-302@axsome.com · 2123325061
All locations (40)
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Tucson, Arizona, United States
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Bellflower, California, United States
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Chino, California, United States
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Glendale, California, United States
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Imperial, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Walnut Creek, California, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Norcross, Georgia, United States
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Snellville, Georgia, United States
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Chicago, Illinois, United States
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Pikesville, Maryland, United States
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Springfield, Massachusetts, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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The Bronx, New York, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol · TrialPath