Recruiting
Phase 3

Solriamfetol

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT07484217

Conditions

Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Solriamfetol 150 MG

Placebo

Study Details

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.

Conditions

Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Study ID

NCT07484217

Start date

Feb 23, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

508 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Solriamfetol 150mg

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

placebo comparator: Placebo

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

Interventions

Solriamfetol 150 MG

Solriamfetol tablets, taken once daily

Placebo

Placebo tablets, taken once daily

Primary outcome measure

  • Time from randomization to relapse of depressive symptoms [ Time Frame: Up to 24 weeks. ]

Central Contacts and Locations

Central contacts

Study Director

2123325061sol-mdd-302@axsome.com

Locations

Clinical Research Site

Recruiting

Tucson, Arizona, United States, 85704

Clinical Research Site

Recruiting

Bellflower, California, United States, 90706

Clinical Research Site

Recruiting

Chino, California, United States, 91710

Clinical Research Site

Recruiting

Glendale, California, United States, 91206

Clinical Research Site

Recruiting

Imperial, California, United States, 92251

Clinical Research Site

Recruiting

Los Angeles, California, United States, 90015

Clinical Research Site

Recruiting

Oceanside, California, United States, 92056

Clinical Research Site

Recruiting

Redlands, California, United States, 92374

Clinical Research Site

Recruiting

San Diego, California, United States, 92123

Clinical Research Site

Recruiting

Sherman Oaks, California, United States, 91403

Clinical Research Site

Recruiting

Walnut Creek, California, United States, 94596

Clinical Research Site

Recruiting

Jacksonville, Florida, United States, 32256

Clinical Research Site

Recruiting

Miami, Florida, United States, 33122

Clinical Research Site

Recruiting

Miami, Florida, United States, 33176

Clinical Research Site

Recruiting

Atlanta, Georgia, United States, 30331

Clinical Research Site

Recruiting

Norcross, Georgia, United States, 30092

Clinical Research Site

Recruiting

Snellville, Georgia, United States, 30078

Clinical Research Site

Recruiting

Chicago, Illinois, United States, 60634

Clinical Research Site

Recruiting

Pikesville, Maryland, United States, 21208

Clinical Research Site

Recruiting

Springfield, Massachusetts, United States, 01103

Clinical Research Site

Recruiting

Las Vegas, Nevada, United States, 89102

Clinical Research Site

Recruiting

Las Vegas, Nevada, United States, 89119

Clinical Research Site

Recruiting

Cherry Hill, New Jersey, United States, 08002

Clinical Research Site

Recruiting

Toms River, New Jersey, United States, 08755

Clinical Research Site

Recruiting

Brooklyn, New York, United States, 11235

Clinical Research Site

Recruiting

New York, New York, United States, 10036

Clinical Research Site

Recruiting

New York, New York, United States, 10128

Clinical Research Site

Recruiting

Staten Island, New York, United States, 10314

Clinical Research Site

Recruiting

The Bronx, New York, United States, 10464

Clinical Research Site

Recruiting

Cincinnati, Ohio, United States, 45215

Clinical Research Site

Recruiting

Cincinnati, Ohio, United States, 45245

Clinical Research Site

Recruiting

Edmond, Oklahoma, United States, 73013

Clinical Research Site

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Clinical Research Site

Recruiting

Portland, Oregon, United States, 97210

Clinical Research Site

Recruiting

Memphis, Tennessee, United States, 38119

Clinical Research Site

Recruiting

Austin, Texas, United States, 78759

Clinical Research Site

Recruiting

Bellaire, Texas, United States, 77401

Clinical Research Site

Recruiting

Dallas, Texas, United States, 75243

Clinical Research Site

Recruiting

Houston, Texas, United States, 77007

Clinical Research Site

Recruiting

San Antonio, Texas, United States, 78240

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2026-07-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.