A Phase 2/3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in the Treatment of Adults with Generalized Anxiety Disorder
We're researching a new potential medicine, Ulotaront, for adults who experience generalised anxiety disorder. This condition causes people to feel worried or anxious about many things, most of the time. The main goal of our study is to find out if Ulotaront can effectively reduce these anxiety symptoms and how safe it is compared to a dummy pill (placebo). Participants will be randomly assigned to receive either Ulotaront or the placebo. Neither the patient nor their doctor will know who is getting which. We will regularly check how anxiety levels change throughout the study using a standard scale. This research aims to offer a new treatment option for those living with anxiety.
At a glance
What is this study about?
This research study is looking into a new treatment called Ulotaront for adults who have generalised anxiety disorder. This is a common condition where people feel worried or anxious about many different things, most of the time, often making it hard to relax or concentrate. Finding effective and safe ways to help manage these feelings is very important.
In this study, we want to see if Ulotaront can help reduce the symptoms of anxiety. We will also be carefully checking for any side effects to make sure it's safe to use. To do this fairly, we're comparing Ulotaront with a 'placebo', which looks exactly like the medicine but doesn't contain any active drug. This helps us understand if any improvements are truly due to the new medicine or if they might happen anyway.
This study is in 'Phase 2/3', meaning it's a later stage of research. We've already done some early checks, and now we're testing it with more people to get a clearer picture of how well it works and if it's safe enough for wider use. The results from studies like this are crucial for developing new medicines that could improve the lives of many people.
Key takeaways
- This study is testing a new medicine (Ulotaront) for generalised anxiety disorder.
- It aims to see if Ulotaront helps reduce anxiety and is safe.
- Some people will get Ulotaront, others a dummy pill (placebo).
- You won't know which one you're getting, nor will your doctor.
- Participation involves regular clinic visits and health checks.
- You can leave the study at any time without affecting your normal care.
Who may be eligible?
This study is designed for adults aged 18 and over. There's no upper age limit, so people of all adult ages can take part. Both men and women are welcome to participate in this research.
You would need to have a diagnosis of generalised anxiety disorder to be considered for the study. There will also be other specific health requirements and checks to make sure the study is a good fit for you and that taking part would be safe.
It's important to discuss your full medical history with the study doctors, as certain health conditions or medications might mean you can't join. The research team will explain all the requirements clearly to make sure you understand.
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 18 years old or older?
- Do you have a diagnosis of generalised anxiety disorder?
- Are you able to attend regular clinic appointments?
- Are you willing to take study medication as prescribed?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to either receive the new medicine (Ulotaront) or a dummy pill (placebo). You wouldn't know which one you're getting, and neither would your study doctor. You would have regular visits to the study clinic where doctors and nurses would check on your health and how you're feeling. These visits would involve discussions, answering questionnaires about your anxiety, and possibly some physical checks or blood tests.
You would take the study medication as prescribed for a a specific length of time. Throughout the study, your anxiety levels would be assessed using a special scale called the Hamilton Anxiety Rating Scale (HAM-A), and your overall condition would be checked with another scale called the Clinical Global Impression-Severity (CGI-S). After the treatment period, there would be follow-up appointments to monitor your health. The study team will explain the total duration of your involvement, including all visits and follow-ups, during the initial screening process.
Potential risks and benefits
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Common questions
What is 'generalised anxiety disorder'?
It's when someone feels overly worried or anxious about many different things, most days, making it hard to relax or concentrate.
What is Ulotaront?
Ulotaront is a new medicine being tested to see if it can help reduce anxiety symptoms in adults.
What does 'placebo' mean?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the real medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, you won't know, and neither will your study doctor. This is called 'double-blind' and helps ensure the study results are unbiased.
How long will the study last for me?
The study team will tell you the exact duration of your participation, including all treatment and follow-up visits, during the initial discussions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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