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

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07484217

Acronym

CLARITY

Enrollment

508

Registered

2026-03-20

Start date

2026-02-23

Completion date

2028-12-01

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Keywords

Solriamfetol, Sunosi, Major Depressive Disorder with excessive daytime sleepiness, Major Depressive Disorder, MDD, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist, Excessive daytime sleepiness, EDS

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.

Detailed description

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.

Interventions

DRUGSolriamfetol 150 MG

Solriamfetol tablets, taken once daily

DRUGPlacebo

Placebo tablets, taken once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time from randomization to relapse of depressive symptoms	Up to 24 weeks.

Countries

United States

Contacts

CONTACTStudy Director

sol-mdd-302@axsome.com2123325061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026