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Could Immune-Boosting drugs treat certain psychosis?

NCT ID NCT03194815

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2017

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

16 to 70 years

Sex

Anyone

Healthy volunteers

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

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

  • Cambridge University Hospitals NH Foundation Trust

    Cambridge, United Kingdom

  • King's College Hospital NHS Foundation Trust

    London, United Kingdom

  • NHS Greater Glasgow and Clyde

    Glasgow, United Kingdom

  • Nottingham University Hospitals NHS Trust

    Nottingham, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, United Kingdom

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, United Kingdom

  • Salford Royal NHS Foundation Trust

    Manchester, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, United Kingdom

  • The Walton Centre NHS Foundation Trust

    Liverpool, United Kingdom

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG, United Kingdom

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