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

NCT07484217 · Axsome Therapeutics, Inc.

Recruiting

In plain English

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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: 2026-03-20

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