Does your depression make it hard to stay awake during the day, even if you get enough sleep at night?
See if the CLARITY study for major depressive disorder (MDD) with excessive daytime sleepiness (EDS) is right for you.
Who Can Participate?
The CLARITY MDD with EDS study is looking for adults who*:
- Are ages 18-65
- Are currently experiencing an episode of depression that has lasted at least 4 weeks
- Sleep, on average, at least 6 hours per night but have a hard time staying awake during the day and feel excessively sleepy during the day
- Don't have any other sleep disorders, like narcolepsy or obstructive sleep apnea (OSA)
How Can I Participate?
Step 1
Complete the online questionnaire here to see if you may be eligible!
Step 2
If you meet certain conditions and want to learn more, your information will be sent to a study site near you.
Step 3
Study site staff will contact you to talk more about the study and get more information on your health history. You may be invited to the study site for a first visit.
Step 4
At the study site, the study doctor and their team will talk to you about participation in the study. After you have asked all of your questions, you will be asked to sign a consent form.
Click the button below to fill out a quick form to see if you may be eligible for the CLARITY study.
By filling out this form, you are under no obligation to participate in the study. Your information will be forwarded to the study site closest to you where a member of the staff will reach out via phone, email, or text to collect more information.
About the Study
The goal of the CLARITY study is to see if the investigational medicine (solriamfetol) is safe and effective in adults with major depressive disorder with excessive daytime sleepiness.
Solriamfetol is approved by the FDA for adults who have excessive daytime sleepiness due to obstructive sleep apnea (OSA) and narcolepsy, which are sleep disorders. Solriamfetol is an investigational treatment for MDD with EDS, meaning it has not yet been approved by any health authority for the treatment of MDD with EDS.
Compensation for time and travel may be available. People who participate in the study will receive study-related care at no cost and you don’t need to have health insurance to participate. Each participant’s MDD and overall health will be looked after by a study physician and staff.
What to Expect
If you are eligible and choose to participate in the CLARITY study, participation will last up to 39 weeks (approximtely 9 months) and includes up to 22 in-person and up to 15 remote visits. It is important to understand how many visits you will need to attend when making the decision to participate.
Screening Period
(Up to 4 weeks)
This is the time when the study doctor and staff determine if you are eligible for the study. You will come in for the first visit to answer some questions and do some medical tests to see if you may be a good fit for the study.
Open-Label Period
(Up to 10 weeks)
If you are eligible to continue in the study, you will then enter the open-label period which lasts up to 10 weeks and includes up to 8 in-person visits and up to 3 remote visits.
All participants will take solriamfetol during this time. It is called “open-label” because both you and the study doctor will know what you are taking.
Double-Blind Period
(Up to 24 weeks)
In the double-blind period, you will either continue receiving solriamfetol or switch to placebo for up to 24 weeks. This period of the study includes up to 13 in-person visits and up to 12 remote visits.
This period is called “double-blind” because neither you nor the study doctor will know if you are taking solriamfetol or placebo. A placebo is a pill that looks like the study medicine but does not contain any active medicine.
At the in-person visits, you can expect some of the following assessments:
Vital Signs
ECG
Review of Medical History
Blood and Urine Samples
Health Questionnaires
Review of Any Side Effects
Why Participate?
If you’re living with depression and excessive daytime sleepiness, the CLARITY study may be right for you. If you are eligible to participate:
- You may receive the investigational medicine
- You may receive study-related care and study evaluations at no cost
- You may also receive compensation for your time and travel
- You may have the opportunity to help advance potential new treatments for people with depression with excessive daytime sleepiness*.
What is MDD with EDS?
Major Depressive Disorder (MDD) is a mental health condition that causes depressed mood and loss of interest over at least a 2-week period. According to the World Heath Organization, depression is the leading cause of disability worldwide, with the US Department of Health and Human Services estimating 21 million US adults experiencing it each year.1,2
Excessive daytime sleepiness (EDS) is a common symptom in patients with MDD, affecting about 50% of this patient population.3 With EDS, patients have an increased chance of falling asleep during the day, even at inappropriate times, which can impact typical daily activities as well as becoming a safety risk. MDD patients with EDS symptoms typically have more severe depression, plus a higher chance of relapse and death.4
References
1. U.S. Department of Health and Human Services, "Key Substance Use and Mental Health Indicators in the United States: Results from the 2020 National Survey on Drug Use and Health," October2021.
2. Baune, B. T., Florea, I., Ebert, B., Touya, M.,Ettrup, A., Hadi, M., & Ren, H., "Patient Expectations and Experiencesof Antidepressant Therapy for Major Depressive Disorder: A Qualitative Study," Neuropsychiatr Dis Treat, vol. 17, pp. 2995-3006, 2021.
3. Hein M, Lanquart JP, Loas G, Hubain P, LinkowskiP. Prevalence and risk factors of excessive daytime sleepiness in major depression: A study with 703 individuals referred for polysomnography. J Affect Disord. 2019 Jan 15;243:23-32.
4. Cheung M M S, Lam S P, Chau S W H, Chan N Y, LiT, Wing Y K, Chan J. Hypersomnolence is associated with non-remission of major depressive disorder. Sleep Medicine 119(2024) 35-43
FAQs
A clinical research study, also called a clinical trial, tests the safety and efficacy of an investigational medicine in human volunteers. Every medication on the market has gone through this process, meaning volunteers are an important part of advancing medicine for present and future generations.
Solriamfetol is the investigational oral medicine being researched in this study. It has been approved by the U.S. Food and Drug Administration (FDA) for people who have excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea (OSA), which are sleep disorders. Solriamfetol is an investigational treatment for MDD with EDS, meaning it has not yet been approved by any health authority for the treatment of MDD with EDS. In this study, researchers want to know if solriamfetol can improve depression symptoms and wakefulness and is safe for use in this indication.
Clinical studies can be sponsored, or funded, by a pharmaceutical or biotechnology company, academic medical center, or health care provider. Every clinical study is held at one or more sites that are led by a principal investigator (study doctor) and their research team.
A placebo looks like the investigational medicine but does not contain any active ingredients (medicine). Taking placebo is as if the participant was not taking anything at all. In this study, placebo is used to compare the effects of the investigational medicine. Neither the participant nor the study doctor will know if they are taking the investigational medicine or placebo. In case of a medical emergency, the study doctor will be able to find out which group the participant belongs to.
In order to participate in a study, you will need to first take some tests and discuss your medical history with the study doctor to ensure that you meet all criteria for participation. You will also review and sign an informed consent form which lays out what will happen in the study, your rights and responsibilities as a participant, and the risks and potential benefits of the study. Once you are eligible and enrolled, you will visit the study site regularly to monitor your progress and overall health. Yes, study participation is absolutely voluntary. You have the right to end participation at any time for any reason. In case you decide to drop out of the study, please speak with the study doctor first.
For more information about the study, visit https://clinicaltrials.gov/study/NCT07484217. For more information about Axsome Therapeutics, the study sponsor, visit axsome.com.