Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
This important study is designed for people living with a specific sleep problem called Delayed Sleep-Wake Phase Disorder (DSWPD). If you have DSWPD, your natural body clock is out of sync with regular daylight hours, making it very hard to fall asleep at a 'normal' time and wake up when you need to. We're testing a new medicine called tasimelteon against a dummy pill (placebo) to see if it can help reset this sleep pattern. We want to find out if tasimelteon helps people with DSWPD sleep at more helpful times and if it's safe to use. This will be a carefully run study where neither you nor the doctors will know if you're getting the active medicine or the placebo, ensuring fair results.
At a glance
What is this study about?
This research study is all about understanding and potentially helping people who have a condition called Delayed Sleep-Wake Phase Disorder, or DSWPD for short. If you have DSWPD, it means your internal body clock, which tells you when to sleep and wake up, is naturally set much later than most people's. This often means you can't fall asleep until the early hours of the morning, and then struggle to wake up until much later in the day, even if you want to. This can make it very difficult to go to school, work, or have a social life at 'normal' times.
The study aims to see if a new medicine, tasimelteon, can help adjust this natural sleep clock. We're comparing tasimelteon to a 'placebo', which is a dummy pill that looks exactly like the real medicine but contains no active ingredients. This helps us ensure that any changes we see are truly due to the medicine and not just other factors or a person's expectation of feeling better. By carefully comparing both groups, we can learn if tasimelteon is an effective and safe way to help people with DSWPD get their sleep patterns in line with their daily lives.
Finding better ways to manage DSWPD is really important because this condition can significantly affect a person's quality of life. By taking part in this study, you could be helping us find new treatments that could improve sleep and daily functioning for many people in the future.
Key takeaways
- The study is for people with Delayed Sleep-Wake Phase Disorder (DSWPD).
- It tests a new medicine, tasimelteon, against a dummy pill (placebo).
- The aim is to see if tasimelteon helps reset sleep patterns and is safe.
- Participation involves taking a daily pill and regular clinic visits.
- You have the right to leave the study at any time without affecting your care.
Who may be eligible?
To join this study, we're looking for adults aged between 18 and 75 years old who have been formally diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD). You'll need to be generally in good health, with a body mass index (BMI) — a measure of your weight compared to your height — that falls between 18 and 35. You'll also need to be able to understand what the study involves and agree to take part by signing a consent form.
There are also some reasons why you might not be able to join. For example, if you've had a recent severe mental health problem that needed treatment changes, or if you've had major surgery, a serious illness, or were unable to move for several days within the last month. We also can't include people who are pregnant, have recently given birth, are breastfeeding, or test positive for recreational drug use. Similarly, if you currently use tobacco products, you wouldn't be able to participate. These rules are in place to make sure the study is as safe as possible for everyone involved and that we get clear results.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 75 years old?
- Have you been diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD)?
- Is your BMI (weight-to-height ratio) between 18 and 35?
- Have you *not* had a mental health condition worsen or needed treatment changes in the last 3 months?
- Are you *not* pregnant, recently pregnant, or breastfeeding?
- Do you *not* currently use tobacco products?
What does participation involve?
If you decide to take part, you'll be given either the study medicine (tasimelteon) or a dummy pill (placebo) to take once a day. You won't know which one you're getting, and neither will the study doctors. You'll have regular visits to the clinic so the study team can check on your health, how you're sleeping, and if the medication is having any effects. These visits will involve answering questions about your sleep, general wellbeing, and possibly having some health checks like blood tests. The study will last for a set period, and it's important to attend all your scheduled appointments. More details on the exact number and timing of visits would be provided during the screening process.
Potential risks and benefits
Locations (17)
- Vanda Investigational SiteVerified postcodeLos Angeles, United States· Recruiting
- Vanda Investigational SiteVerified postcodeRedwood City, United States· Recruiting
- Vanda Investigational SiteVerified postcodeAurora, United States· Recruiting
- Vanda Investigational SiteVerified postcodeBoston, United States· Recruiting
- Vanda Investigational SiteVerified postcodeSt Louis, United States· Recruiting
- Vanda Investigational SiteVerified postcodeNew Hyde Park, United States· Recruiting
- Vanda Investigational SiteVerified postcodeCincinnati, United States· Recruiting
- Vanda Investigational SiteVerified postcodeCleveland, United States· Recruiting
- Vanda Investigational SiteVerified postcodeColumbia, United States· Recruiting
- Vanda Investigational SiteVerified postcodeSan Antonio, United States· Recruiting
- Vanda Investigational SiteVerified postcodeSherman, United States· Recruiting
- Vanda Investigational SiteVerified postcodeInnsbruck, Austria· Active not recruiting
Common questions
What is Delayed Sleep-Wake Phase Disorder (DSWPD)?
It's a sleep problem where your body's natural clock makes you fall asleep and wake up much later than typical, making it hard to follow a regular schedule.
What is tasimelteon?
Tasimelteon is the medicine being tested in this study. It's designed to help adjust your body's sleep-wake cycle.
What is a 'placebo'?
A placebo is a dummy pill that looks like the real medicine but has no active ingredients. It helps us see if the actual medicine truly works.
Will I know if I'm getting the medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the study team will know until after the study has finished. This ensures the results are fair.
How long does the study last?
The overall duration of the study would be explained in more detail if you are considered for participation, as it varies for each study.
How to find out more
Vanda Pharmaceuticals Inc.
Always speak to your GP or specialist before deciding to take part in a study.
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