NCT07484217

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
508

participants targeted

Target at P50-P75 for phase_3

Timeline
30mo left

Started Feb 2026

Typical duration for phase_3

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 23, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Keywords

SolriamfetolSunosiMajor Depressive Disorder with excessive daytime sleepinessMajor Depressive DisorderMDDAxsomeNon-stimulant therapyDopamine norepinephrine reuptake inhibitorTrace amine-associated receptor 1 (TAAR1) agonistExcessive daytime sleepinessEDS

Outcome Measures

Primary Outcomes (1)

  • Time from randomization to relapse of depressive symptoms

    Up to 24 weeks.

Study Arms (2)

Solriamfetol 150mg

EXPERIMENTAL

* In the open-label period; * In the randomized double-blind period (if applicable)

Drug: Solriamfetol 150 MG

Placebo

PLACEBO COMPARATOR

• In the randomized double-blind period (if applicable)

Drug: Placebo

Interventions

Solriamfetol 150 MGDRUG

Solriamfetol tablets, taken once daily

Solriamfetol 150mg
PlaceboDRUG

Placebo tablets, taken once daily

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Clinical Research Site

Chino, California, 91710, United States

RECRUITING

Clinical Research Site

Redlands, California, 92374, United States

RECRUITING

Clinical Research Site

Walnut Creek, California, 94596, United States

RECRUITING

Clinical Research Site

Jacksonville, Florida, 32256, United States

RECRUITING

Clinical Research Site

Miami, Florida, 33176, United States

RECRUITING

Clinical Research Site

Cherry Hill, New Jersey, 08002, United States

RECRUITING

Clinical Research Site

Toms River, New Jersey, 08755, United States

RECRUITING

Clinical Research Site

Brooklyn, New York, 11235, United States

RECRUITING

Clinical Research Site

The Bronx, New York, 10464, United States

RECRUITING

Clinical Research Site

Cincinnati, Ohio, 45215, United States

RECRUITING

Clinical Research Site

Portland, Oregon, 97210, United States

RECRUITING

Clinical Research Site

Memphis, Tennessee, 38119, United States

RECRUITING

Clinical Research Site

Dallas, Texas, 75243, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDisorders of Excessive Somnolence

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Study Director

CONTACT

2123325061sol-mdd-302@axsome.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(13)