Active not recruitingPHASE2INTERVENTIONAL

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

This study, called SINAPPS2, is investigating new treatments for a type of mental health condition called psychosis. Specifically, it's for people whose psychosis is thought to be caused by 'autoimmune encephalitis', where the body's immune system mistakenly attacks its own brain cells. Often, certain antibodies (special proteins) can be found in the blood or spinal fluid in these cases. The study is testing two medicines, intravenous immunoglobulin (IVIG) and rituximab, to see if they can help improve symptoms. Researchers want to find out if these treatments are safe and if they really work better than a dummy treatment (placebo) in people aged 16 to 70. The goal is to provide better care for those with this specific type of psychosis.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University of Cambridge

Enrolment target

Start

01 Nov 2017

Estimated completion

30 Apr 2027

Psychosis Autoimmune Encephalitis

What is this study about?

Imagine your body's immune system, which normally fights off germs, sometimes gets confused and starts attacking parts of your own body. When this happens to certain brain cells, it can lead to problems with thinking, feelings, and behaviour, which doctors call psychosis. This study is for people who have psychosis that doctors believe is caused by these specific immune system attacks.

The study aims to test two immune-modulating treatments: intravenous immunoglobulin (IVIG) and rituximab. IVIG is a treatment made from donated human blood that contains antibodies to help calm down an overactive immune system. Rituximab is another medicine that helps to reduce certain types of immune cells. The idea behind using both is that IVIG might act quickly to reduce symptoms, while rituximab could help keep the improvements going for longer.

Researchers want to see if these treatments can improve the symptoms of psychosis and whether they are safe to use. Half the people in the study will receive the active treatments, and the other half will get a dummy treatment (placebo). This is done so doctors can accurately compare how well the real medicines work against no active treatment. By doing this carefully, the study hopes to find new ways to help people with this specific type of psychosis.

Key takeaways

This study is for psychosis linked to the immune system.
It tests two medicines: IVIG and rituximab.
Half of participants will get a dummy treatment (placebo).
It aims to find safer and more effective treatments.
Participation involves regular hospital visits for treatment and checks.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to meet certain conditions. Your psychosis must have started fairly recently, within the last two years, and could be your first experience of psychosis or a return of symptoms after getting better. A key requirement is that tests show you have specific 'autoantibodies' in your blood or spinal fluid, which are special proteins linked to your immune system attacking brain cells. Also, your current psychosis symptoms must be clear enough to be measured by doctors.

There are also reasons why you might not be able to join. For example, if your current episode of psychosis has been going on for more than two years, or if you have another serious brain condition. The study also cannot include pregnant women, or people with certain infections like Hepatitis or HIV. You also can't be in the study if you have conditions that would make any of the study medicines unsafe for you, or if you are already taking part in another similar clinical trial.

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.

Is my current psychosis episode less than two years old?
Have my doctors found special 'autoantibodies' in my blood or spinal fluid?
Am I aged between 16 and 70 years old?
Do I have any serious infections like Hepatitis or HIV?
Am I pregnant or planning to become pregnant during the study?
Do I have any other serious neurological conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to either receive the active treatments (IVIG and rituximab) or a dummy treatment (placebo). Neither you nor your study doctor will know which one you are receiving – this is called 'double-blinded'.

Your treatment will start with IVIG given over 4 days. Around 3-4 weeks later, you'll have two doses of rituximab, given 14 days apart. You will have regular visits to the hospital or clinic so the study team can monitor your health, check your psychosis symptoms, and carry out blood tests. The exact number of visits and tests will be explained to you in detail by the study team. The total duration of your active participation in the study will last for a number of months, including follow-up appointments after your treatment.

Potential risks and benefits

Potential benefits of taking part include the possibility that the study treatments could improve your psychosis symptoms, especially if your condition is indeed caused by your immune system. You would also be contributing to medical knowledge that could help many others in the future. However, there's no guarantee the treatment will help you, especially if you receive the placebo. Potential risks could include side effects from the medications, such as allergic reactions, fever, headaches, or infections, as well as discomfort from blood tests and IV lines. All known or potential risks will be thoroughly explained to you. Remember, joining this study is completely your choice, and you can withdraw at any time without giving a reason, and it will not affect your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cambridge University Hospitals NH Foundation Trust
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Cambridge, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
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Exeter, United Kingdom
NHS Greater Glasgow and Clyde
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Glasgow, United Kingdom
The Walton Centre NHS Foundation Trust
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Liverpool, United Kingdom
University College London Hospitals Nhs Foundation Trust
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London, United Kingdom
King's College Hospital NHS Foundation Trust
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London, United Kingdom
Salford Royal NHS Foundation Trust
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Manchester, United Kingdom
Nottingham University Hospitals NHS Trust
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Nottingham, United Kingdom
Oxford University Hospitals NHS Foundation Trust
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Oxford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
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Sheffield, United Kingdom

Common questions

What is psychosis?

Psychosis is a mental health condition where a person experiences some loss of contact with reality, which can involve seeing or hearing things that aren't there, or having unusual beliefs.

What does 'autoimmune encephalitis' mean?

It means your body's immune system, which normally fights off infections, mistakenly attacks your own brain, causing inflammation and affecting how your brain works.

What are IVIG and rituximab?

These are medicines that help to control or calm down your immune system. IVIG is made from human blood, and rituximab targets specific immune cells.

Will I know if I'm getting the real medicine or the dummy treatment?

No, neither you nor your doctor will know during the study. This is to make sure the study results are as fair and accurate as possible.

What happens if I decide to leave the study early?

You can leave the study at any time, for any reason. Your decision will not affect your regular medical care.