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New treatment option for Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Official title Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
ClinicalTrials.gov ID: NCT07484217
What this study is testing
What is Solriamfetol 150 MG?
Solriamfetol 150 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder with excessive daytime sleepiness symptoms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 likely can't join 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
The study team makes the final eligibility decision.
Where it's taking place
- Chino, California, United States
- Redlands, California, United States
- Walnut Creek, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Cherry Hill, New Jersey, United States
- Toms River, New Jersey, United States
- Brooklyn, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chino, California, United States; Redlands, California, United States; Walnut Creek, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Cherry Hill, New Jersey, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.