The efficacy of xanomeline-trospium in treating cognitive impairment in patients with a psychotic disorder
This study is testing a new medicine called xanomeline-trospium for people aged 18 to 55 who have early psychosis, such as schizophrenia. Many people with psychosis also struggle with thinking, memory, and attention. While current medicines help with other symptoms, they often don't improve these thinking skills. The study wants to find out if xanomeline-trospium is better at helping with these cognitive (thinking) problems than two common existing medicines. Participants will be given either the new medicine or one of the usual ones for 6 weeks, without knowing which they receive. Researchers hope to find better ways to help people with psychosis with their thinking and memory.
At a glance
What is this study about?
Psychosis is a mental health condition where people might see or hear things that others don't, or have strong beliefs that aren't based in reality. For many people with psychosis, it's also common to have difficulties with concentration, remembering things, or thinking clearly. These are often called 'cognitive symptoms'. Current medicines for psychosis are usually good at helping with hallucinations and strong beliefs, but they often don't do much to improve these thinking and memory problems.
This study is testing a new medicine called xanomeline-trospium. It works in a different way to current medicines. Researchers want to compare xanomeline-trospium with two medicines often used for psychosis (risperidone and lurasidone). The main goal is to see if xanomeline-trospium is better at helping with those tricky thinking and memory problems in people who have recently been diagnosed with psychosis.
We hope this study will give us important information about whether this new medicine could be a better option for people living with psychosis, particularly for improving their day-to-day thinking skills. The information gathered will help doctors and researchers develop better treatments in the future.
Key takeaways
- The study tests a new medicine for people with early psychosis.
- It aims to improve thinking, memory, and concentration skills.
- Compares a new medicine (xanomeline-trospium) with two standard treatments.
- Involves a 6-week main phase, with an optional longer-term follow-up.
- Participants can get paid for their time and travel.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults aged between 18 and 55 years old.
To take part, you need to have been recently diagnosed with a type of psychosis, such as schizophrenia, schizoaffective disorder, or schizophreniform disorder. You also need to have received antipsychotic medication before, and be open to either starting a new medication or switching from your current one. It's important that you can understand and speak English.
There's also a separate group of healthy volunteers who won't take any study medicine but will help by completing assessments for comparison. They need to be willing to have brain scans.
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, schizoaffective disorder, or schizophreniform disorder?
- Have you had psychosis for less than 10 years?
- Have you used antipsychotic medicine before, and are you open to changing or starting a new one?
- Can you understand and communicate in English?
What does participation involve?
If you decide to take part in the main study group (for people with early psychosis), you will be assigned by chance, like flipping a coin, to receive either xanomeline-trospium or one of two commonly used medicines (risperidone or lurasidone). For the first 6 weeks, neither you nor the study team will know which medicine you are receiving.
During these 6 weeks, you will have three visits: at the start, after 3 weeks, and at 6 weeks. At these visits, you'll do tests to check your memory and thinking, and we'll look at your symptoms, how you're managing daily life, and your general wellbeing. Some visits might also include blood tests and optional brain scans.
After 6 weeks, you'll be told which medicine you were taking. If you were on xanomeline-trospium, you might have the option to continue taking it for another year in a longer, open-label part of the study, where both you and the team would know what you're taking. This longer part would involve one main visit after a year and three quick phone calls every three months to check on you. The total duration for the main study is 6 weeks, but some might continue for up to 1 year and 6 weeks.
Potential risks and benefits
Locations (2)
- Warneford HospitalApproximateOxford, England
- Kings College HospitalApproximateLondon, England
Common questions
What is psychosis?
Psychosis is a mental health condition where a person might experience things like hearing voices or having beliefs that others don't share. It can also affect how a person thinks and remembers things.
What are 'cognitive symptoms'?
Cognitive symptoms mean problems with thinking skills, like difficulty concentrating, remembering things, or paying attention.
Will I know which medicine I'm getting?
For the first 6 weeks, neither you nor the study team will know which medicine you are taking. This helps make the study fair and accurate. After 6 weeks, you will be told.
How long will I be in the study?
The main part of the study lasts 6 weeks. If you receive xanomeline-trospium, you might have the option to continue for another year, making it about 1 year and 6 weeks in total.
Do I have to do the brain scans?
No, the brain scans are optional. You can choose not to have them and still take part in the rest of the study.
How to find out more
Michael Sinden
Always speak to your GP or specialist before deciding to take part in a study.
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