Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
This research study is looking into a new medication called NBI-1117570 for adults with schizophrenia. The main goal is to find out if this new medicine can help improve the challenging thoughts and feelings (sometimes called behavioural and psychological symptoms) that people experience during an acute flare-up of their condition. Participants in this study will be adults aged 18 to 55 who are currently in hospital due to their schizophrenia symptoms. Some participants will receive the new medicine, while others will get a placebo (a dummy pill with no active ingredients) to compare the effects. This will help doctors understand if NBI-1117570 is an effective and safe treatment option.
At a glance
What is this study about?
Schizophrenia is a complex mental health condition that can affect how a person thinks, feels, and behaves. Sometimes, people with schizophrenia experience a sudden worsening of their symptoms, often called an 'acute flare-up'. When this happens, they might need to stay in hospital for support and treatment.
This study is testing a new medicine called NBI-1117570. The researchers want to see if this new medicine can help people who are experiencing an acute flare-up of their schizophrenia symptoms. They will compare it to a 'placebo', which is a pill that looks exactly like the study medicine but doesn't contain any active drug. This comparison helps doctors understand if any improvements seen are truly due to the new medicine or if they might happen naturally or due to other care.
The main aim of this study is to check if NBI-1117570 can effectively reduce the challenging thoughts, feelings, and behaviours associated with schizophrenia during these flare-ups. Learning more about new treatments like this is important because it could lead to better ways to help people manage their condition and improve their quality of life.
Key takeaways
- This study is for adults (18-55) in hospital with a schizophrenia flare-up.
- It tests a new medicine (NBI-1117570) against a dummy pill (placebo).
- The goal is to see if the new medicine improves schizophrenia symptoms.
- Your safety and well-being are the top priority throughout the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 55 years old and have been diagnosed with schizophrenia for at least one year. You must also be currently in hospital because of a recent flare-up of your schizophrenia symptoms, which started less than two months ago. It's also important that you've had a positive response to at least one antipsychotic medicine for a previous flare-up (though not clozapine).
There are also some reasons why you might not be able to join. For example, if there's a serious risk to your safety or the safety of others, or if you have a history of seizures or fits. Certain heart conditions, being pregnant or breastfeeding, or taking medications that might interfere with the study medicine, would also mean you couldn't take part. The study team will review all your medical information carefully to make sure it's safe for you to participate.
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 55 years old?
- Have you been diagnosed with schizophrenia for at least one year?
- Are you currently in hospital due to a schizophrenia flare-up that started recently?
- Have you responded well to another antipsychotic medicine (not clozapine) for a past flare-up?
- Do you have a history of seizures or serious heart conditions?
- Are you pregnant or breastfeeding?
What does participation involve?
If you decide to take part, you'll be part of a group helping to test this new medicine. You would receive either the new medicine, NBI-1117570, or a placebo (a dummy pill). You won't know which one you are getting, and neither will your doctors, to ensure the results are fair. You'll have regular visits where doctors will check your health, ask about your symptoms, and do medical tests. This is to make sure the medicine is safe and to see if it's helping. The study will continue as long as you need to be in hospital for this episode, and potentially beyond, though the exact duration isn't specified here.
Potential risks and benefits
Locations (5)
- Neurocrine Clinical SiteVerified postcodeKazanlak, Bulgaria· Recruiting
- Neurocrine Clinical SiteVerified postcodePazardzhik, Bulgaria· Recruiting
- Neurocrine Clinical SiteVerified postcodeTargovishte, Bulgaria· Recruiting
- Neurocrine Clinical SiteVerified postcodeLondon, United Kingdom· Recruiting
- Neurocrine Clinical SiteVerified postcodeOxford, United Kingdom· Recruiting
Common questions
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine.
Will I know if I'm getting the new medicine or the placebo?
No, neither you nor your doctors will know if you are receiving the new medicine or the placebo. This is to keep the study fair and accurate.
What happens if the new medicine doesn't work for me?
Your health will be closely monitored. If the medicine isn't helping or if your symptoms worsen, the study doctors will adjust your care as needed, just like in standard treatment.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
Will my regular doctors still be involved in my care?
Yes, your usual medical team will continue to be involved and informed about your care, working alongside the study team.
How to find out more
Neurocrine Medical Information Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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