A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Patients with Schizophrenia, Followed by an Open-label Extension Phase
This research study is testing a new medication, SEP-363856, for people diagnosed with schizophrenia who are having an acute episode, meaning their symptoms are particularly strong right now. The main goal is to find out if this new medicine can help improve their symptoms over 6 weeks and if it is safe. Participants in the study will be split into groups; some will receive SEP-363856, and others will receive a 'placebo', which looks like the study drug but contains no active medicine. This allows us to properly compare the effects. There will also be a longer-term part of the study where everyone gets the active medicine. This is a common way to test new medicines.
At a glance
What is this study about?
This study is about exploring a new medication called SEP-363856 for adults who have schizophrenia and are currently experiencing strong symptoms, sometimes called an 'acute psychotic episode'. Schizophrenia is a mental health condition that can affect how a person thinks, feels, and behaves. When symptoms are acute, it means they are particularly noticeable and can be very challenging.
The main purpose of this study is to see how well SEP-363856 works to improve these symptoms over a 6-week period. We also want to understand if it's safe and if people can tolerate taking it. To do this, some people will receive the new medicine, while others will get a 'dummy pill' (a placebo) that looks exactly the same but has no medicine in it. People won't know which one they are taking; this helps us get accurate results.
After this initial 6-week period, there will be an 'open-label extension phase'. This means that everyone who continues in the study after the first 6 weeks will receive the active study medicine. This part of the study helps us learn more about the long-term effects and safety of SEP-363856.
Key takeaways
- This study is testing a new medicine for active symptoms of schizophrenia.
- It aims to see if the medicine is effective and safe over 6 weeks.
- Some participants will receive the active medicine, others a dummy pill.
- All participants will be closely monitored by a medical team.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet other health requirements.
Both men and women are welcome to participate in this research. The most important health requirement is that you have a diagnosis of schizophrenia and are currently experiencing active psychotic symptoms.
Your study doctor will discuss all the requirements with you in detail to make sure this study is the right fit for your health situation.
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 at least 18 years old?
- Do you have a diagnosis of schizophrenia?
- Are you currently experiencing strong, active symptoms of schizophrenia?
- Are you willing to attend regular study appointments?
- Are you able to understand the study and provide your consent?
- Are you comfortable potentially receiving a placebo for the first 6 weeks?
What does participation involve?
If you decide to take part, you'll first have screening appointments to check if the study is right for you. If you qualify, you will receive either the study medicine (SEP-363856) or a look-alike dummy pill (placebo) for the first 6 weeks. You won't know which one you're taking, nor will the study team during this initial phase. You'll need to attend regular visits to the study clinic for assessments, which might include talking about your symptoms, taking questionnaires, and having physical health checks like blood tests and checking your heart.
After these first 6 weeks, if you choose to continue and your health allows, you will then receive the actual study medicine (SEP-363856) in what's called an 'open-label' phase. This means everyone will know they are getting the active medicine. The full duration of your participation could vary, but the initial evaluation period is 6 weeks, followed by a longer period in the open-label phase. You will be closely monitored throughout your time in the study.
Potential risks and benefits
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Common questions
What is 'psychotic' in this study?
It refers to symptoms like hallucinations (seeing or hearing things that aren't there) or delusions (strong beliefs not based on reality) that are currently very active and causing distress.
What does 'double-blind' mean?
It means that neither you nor the doctors treating you will know if you're getting the active study medicine or the dummy pill. This helps ensure the results are as fair as possible.
What is a 'placebo'?
A placebo is a tablet or capsule that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand the true effect of the new medicine.
Will I get medication for free?
Yes, all study medication will be provided at no cost to you during the trial.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, without it affecting your future 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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