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

Conditions

• Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Solriamfetol 150 MG — DRUG
  Solriamfetol tablets, taken once daily
• Placebo — DRUG
  Placebo tablets, taken once daily

Study Details

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.

Key Dates

Start date

Feb 23, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

508 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

• Study Director
  2123325061
  [email protected]

Locations (13)

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