Could Immune-Boosting drugs treat certain psychosis?
NCT ID NCT03194815
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether a combination of intravenous immunoglobulin (IVIG) and rituximab can help people with psychosis caused by antibodies attacking the brain. 70 participants with acute psychosis and specific antibodies receive either the immunotherapy or a placebo. The goal is to see if the treatment speeds up recovery and reduces relapse, while monitoring safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intravenous immunoglobulin (IVIG) and rituximab
- What this could lead to
- If successful, this could point toward a new treatment for psychosis caused by specific brain antibodies, potentially reducing symptoms and relapse.
- What could go wrong
- This is an early-phase trial with only 70 participants, so results may not apply to everyone. Immunotherapy can cause side effects like infusion reactions or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2017
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Acute psychosis \>2 weeks. This may either be first episode or relapse after remission (remission defined as having mild or absent symptoms of psychosis for at least 6 months) * Serum or CSF neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1 and other) * Psychosis symptoms as defined by PANSS ≥4 on at least one of the following items: P1, P2, P3, N1, N4, N6, G5 and G9. Exclusion Criteria: * Current episode of psychosis greater than 24 months duration * Co-existing severe neurological disease * Evidence of current acute encephalopathy * Hepatitis or HIV infection, pregnancy * Contraindications to any trial drug * Concurrent enrolment in another CTIMP
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cambridge University Hospitals NH Foundation Trust
Cambridge, United Kingdom
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King's College Hospital NHS Foundation Trust
London, United Kingdom
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NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
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Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
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Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
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Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom
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Salford Royal NHS Foundation Trust
Manchester, United Kingdom
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Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
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The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom
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University College London Hospitals Nhs Foundation Trust
London, NW1 2PG, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can virtual reality from home sharpen social skills in schizophrenia?