NCT07484217 Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
| NCT ID | NCT07484217 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 508 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 508 participants in total. It began in 2026-02-23 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07484217 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07484217 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 508 participants.
Is NCT07484217 currently recruiting?
Yes, NCT07484217 is actively recruiting participants. Contact the research team at sol-mdd-302@axsome.com for enrollment information.
Where is the NCT07484217 trial being conducted?
This trial is being conducted at Chino, United States, Redlands, United States, Walnut Creek, United States, Jacksonville, United States and 9 additional locations.
Who is sponsoring the NCT07484217 clinical trial?
NCT07484217 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 508 participants.