Major Depressive Disorder With Excessive Daytime Sleepiness SymptomsPhase 3CLARITYNCT07484217
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
A Phase 3 study testing Solriamfetol 150 MG in people with Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms, run by Axsome Therapeutics, Inc. at 40 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
- What is being tested?
- Solriamfetol 150 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 508 participants
- Where
- 40 sitesUnited States
- Study dates
- 23 Feb 2026to Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
United States40 sites, 40 recruiting
- Recruiting
Clinical Research Site
Atlanta, Georgia, 30331
- Recruiting
Clinical Research Site
Austin, Texas, 78759
- Recruiting
Clinical Research Site
Bellaire, Texas, 77401
- Recruiting
Clinical Research Site
Bellflower, California, 90706
- Recruiting
Clinical Research Site
Brooklyn, New York, 11235
- Recruiting
Clinical Research Site
Cherry Hill, New Jersey, 08002
- Recruiting
Clinical Research Site
Chicago, Illinois, 60634
- Recruiting
Clinical Research Site
Chino, California, 91710
- Recruiting
Clinical Research Site
Cincinnati, Ohio, 45215
- Recruiting
Clinical Research Site
Cincinnati, Ohio, 45245
- Recruiting
Clinical Research Site
Dallas, Texas, 75243
- Recruiting
Clinical Research Site
Edmond, Oklahoma, 73013
- Recruiting
Clinical Research Site
Glendale, California, 91206
- Recruiting
Clinical Research Site
Houston, Texas, 77007
- Recruiting
Clinical Research Site
Imperial, California, 92251
- Recruiting
Clinical Research Site
Jacksonville, Florida, 32256
- Recruiting
Clinical Research Site
Las Vegas, Nevada, 89102
- Recruiting
Clinical Research Site
Las Vegas, Nevada, 89119
- Recruiting
Clinical Research Site
Los Angeles, California, 90015
- Recruiting
Clinical Research Site
Memphis, Tennessee, 38119
- Recruiting
Clinical Research Site
Miami, Florida, 33122
- Recruiting
Clinical Research Site
Miami, Florida, 33176
- Recruiting
Clinical Research Site
New York, New York, 10036
- Recruiting
Clinical Research Site
New York, New York, 10128
- Recruiting
Clinical Research Site
Norcross, Georgia, 30092
- Recruiting
Clinical Research Site
Oceanside, California, 92056
- Recruiting
Clinical Research Site
Oklahoma City, Oklahoma, 73116
- Recruiting
Clinical Research Site
Pikesville, Maryland, 21208
- Recruiting
Clinical Research Site
Portland, Oregon, 97210
- Recruiting
Clinical Research Site
Redlands, California, 92374
- Recruiting
Clinical Research Site
San Antonio, Texas, 78240
- Recruiting
Clinical Research Site
San Diego, California, 92123
- Recruiting
Clinical Research Site
Sherman Oaks, California, 91403
- Recruiting
Clinical Research Site
Snellville, Georgia, 30078
- Recruiting
Clinical Research Site
Springfield, Massachusetts, 01103
- Recruiting
Clinical Research Site
Staten Island, New York, 10314
- Recruiting
Clinical Research Site
The Bronx, New York, 10464
- Recruiting
Clinical Research Site
Toms River, New Jersey, 08755
- Recruiting
Clinical Research Site
Tucson, Arizona, 85704
- Recruiting
Clinical Research Site
Walnut Creek, California, 94596
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
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.
Read the 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.
- Being tested
- Solriamfetol 150 MG, Placebo
- 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
- Medical subject headings
- Depressive Disorder, Major, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol 150 MGDrug
Solriamfetol tablets, taken once daily
PlaceboDrug
Placebo tablets, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol 150mg | Experimental | * In the open-label period;
* In the randomized double-blind period (if applicable) Receives: Drug: Solriamfetol 150 MG |
| Placebo | Placebo comparator | • In the randomized double-blind period (if applicable) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to relapse of depressive symptoms
Measured: Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start23 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder With Excessive Daytime Sleepiness SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484217
- Sponsor's protocol ID
- SOL-MDD-302
- Acronym
- CLARITY
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No