Efficacy and Safety of Daridorexant in Patients with Major Depressive Disorder (MDD) and Insomnia: Double-blind, randomized, controlled trial
This research study is investigating a new medicine called Daridorexant. It's designed for people who are experiencing major depression and also have moderate to severe insomnia (long-term difficulty sleeping). The main goal is to find out if Daridorexant helps people sleep better over three months, compared to receiving a dummy pill (placebo). Researchers will check different measures of sleep, how people's depression symptoms change, and if their overall quality of life improves. They will also carefully monitor any side effects to make sure the medicine is safe. This study is in its final phase of looking at how well a medicine works in real-world use.
At a glance
What is this study about?
This study is looking at a medicine called Daridorexant for people who are struggling with two conditions at the same time: major depression and significant trouble sleeping (insomnia). Many people with depression also find it hard to get a good night's sleep, and this can make their depression feel even worse. This research aims to see if Daridorexant can help improve sleep for these individuals.
The study works by giving some people Daridorexant and others a "dummy pill" (placebo). This is a common way to test medicines, as it helps researchers see if the real medicine is truly making a difference, rather than expectations. Neither the participants nor the doctors will know who is getting which pill, which helps keep the results fair and unbiased. The main thing they want to find out is whether Daridorexant helps improve sleep problems over a three-month period.
Beyond just sleep, the researchers will also be checking several other important things. They’ll look at how the medicine affects depression symptoms, overall quality of life, and if there are any side effects. This comprehensive approach helps understand the full impact of the medicine on a person's health and well-being. This is a "Phase 4" study, meaning the medicine has already been studied for safety and basic effectiveness, and now it's being looked at in a broader way, often in specific patient groups like those with both depression and insomnia.
Key takeaways
- The study investigates a new medicine (Daridorexant) for depression and insomnia.
- It aims to improve sleep and depression symptoms over three months.
- Participants will receive either the medicine or a dummy pill.
- Safety and side effects will be carefully monitored.
- The study is for adults aged 18 and over with major depression and significant insomnia.
Who may be eligible?
This study is looking for adults, aged 18 and over, who are experiencing major depression and also have difficulty sleeping (insomnia) that is moderate to severe. Both men and women can take part. The study needs people who fit these descriptions to help understand how the new medicine works for them.
To make sure the study results are clear and accurate, there will be some specific medical and health requirements. For instance, if you have certain other serious health conditions, or if you are taking specific medications that might interfere with the study medicine, you might not be able to participate. This is to ensure your safety and the quality of the research.
The medical team will carefully review your health history and current situation to determine if you are a suitable candidate for this particular study. They will explain all the details and answer any questions you have about what's involved.
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.
- I am 18 years old or older.
- I have been diagnosed with major depression.
- I have moderate to severe trouble sleeping (insomnia).
- I am willing to take a study medicine or dummy pill for three months.
- I am not currently involved in another clinical trial that might conflict with this one.
What does participation involve?
If you decide to take part in this study, you would be given either the Daridorexant medicine or a dummy pill (placebo) to take. You wouldn't know which one you are receiving. The study treatment would last for three months. Throughout this time, you would have clinic visits where the research team would assess your sleep patterns, your depression symptoms, and your general well-being. This might involve filling out questionnaires, having discussions with doctors, and potentially undergoing sleep tests (like polysomnography) that measure your sleep while you're asleep. They would also monitor you closely for any side effects. After the three-month treatment period, there might be some follow-up assessments to see how you are doing.
Potential risks and benefits
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Common questions
What is Daridorexant?
Daridorexant is a new medicine being studied to help people with both depression and sleep problems get better sleep.
Why is this study being done?
This study aims to find out if Daridorexant can effectively improve sleep and depression symptoms for people who suffer from both conditions, and if it's safe to use.
What does 'dummy pill' or 'placebo' mean?
A dummy pill looks like the actual medicine but doesn't contain any active ingredients. It's used to compare against the real medicine to see if it truly works better than nothing.
How long will the study last?
The main treatment period for the study medicine or dummy pill will last for three months. There may be follow-up checks after that.
Can I stop participating if I want to?
Yes, you have the right to leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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