Efficiency of a composite personalised care on functional outcome in early psychosis: A Prospective Randomised Controlled Trial
This research is a 'Phase IV' study, meaning it's looking at existing treatments. It's investigating a unique package of care for people who are at a very high risk of developing psychosis or who have just had their first experience of it. The care package includes a combination of commonly available supplements: a specific type of soluble medicine, folic acid, vitamin B12, and omega-3 fish oil capsules. Researchers want to find out if this personalised approach can help people function better in their daily lives, such as with work, hobbies, and relationships. They will check how well participants are doing about 3 to 4 months after starting the care plan.
At a glance
What is this study about?
This study is designed to explore new and potentially better ways to support young people who are either at a very high chance of developing psychosis or who have recently experienced their first episode. Psychosis is a mental health condition where a person might interpret reality differently from others, sometimes involving hearing or seeing things that aren't there, or having strong beliefs that aren't shared by others. Getting the right care early is really important.
The research is looking at a 'personalised care' approach. This means the support is tailored to the individual. The main focus of this study is on whether adding certain supplements to their usual care can make a difference. The supplements being tested are a specific soluble medicine, folic acid (a type of vitamin B), vitamin B12, and omega-3 fish oil capsules.
The main goal of the study is to see if this special combination of care can help people live more fulfilling and independent lives. They will measure this by looking at how well participants are managing their day-to-day activities, like going to school or work, having social interactions, and generally looking after themselves. This kind of research helps doctors understand the best ways to support people with these conditions in the future.
Key takeaways
- It's about helping people at high risk of psychosis or experiencing it for the first time.
- The study explores a personalised care approach using supplements.
- It aims to improve daily functioning and quality of life.
- All adults (18+) can be considered.
- Your involvement includes taking specific supplements and having regular check-ups.
Who may be eligible?
To be considered for this study, you would need to be 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in the study.
The study is specifically looking for people who are either considered to be at a very high risk of developing psychosis, or who have recently experienced their first episode of psychosis. The research team will have clear ways to check if these criteria apply to you.
It's important to understand that 'early psychosis' refers to the first time someone experiences symptoms, while 'ultra high risk' means that doctors have identified certain signs that suggest a person is more likely to develop psychosis. If you or someone you know fits these descriptions, you might be eligible to learn more about the study.
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?
- Have you recently experienced your first episode of psychosis?
- Or, have doctors told you that you are at a very high risk of developing psychosis?
- Are you able to attend regular appointments for check-ups?
- Are you open to taking specific medication and supplements as part of the study?
What does participation involve?
If you decide to take part in this study, you would be assigned to receive a specific package of care. This care package includes certain supplements: a soluble medicine called MUCODRILL, a folic acid supplement named FOLINORAL, vitamin B12 tablets, and Omacor 1000 mg fish oil capsules. You would take these medicines as prescribed by the study doctors.
The main part of your involvement will be attending regular check-ups with the study team. They will assess how you are feeling and functioning in your daily life. A key part of this assessment will happen about 3 to 4 months after you start the study. These appointments help the researchers understand if the care package is making a positive difference. The total duration of your participation in the study would be explained to you in detail by the research team.
Potential risks and benefits
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Common questions
What is 'psychosis'?
Psychosis refers to a mental health state where a person might experience reality differently, like hearing voices or having strong, unusual beliefs.
What does 'ultra high risk' mean?
It means a person shows certain signs or symptoms that suggest they have a much higher chance of developing psychosis in the future.
What kind of supplements are being used?
The study uses a specific soluble medicine, folic acid (a B vitamin), vitamin B12, and omega-3 fish oil capsules.
Will this care replace my current treatment?
No, this is about adding specific supplements to your existing care, not replacing it. The study will explain how it fits with your current treatment plan.
How long will I be in the study?
The main assessment will be 3-4 months after starting, but the full duration of your participation would be clearly explained by the research team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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