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RECRUITINGPhase 2INTERVENTIONAL

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

A Randomised Phase II Double-blinded Placebo-controlled Trial of Intravenous Immunoglobulins and Rituximab in Patients with Antibody-associated Psychosis (SINAPPS2)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A randomised phase II double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (NMDA-receptor or Voltage Gated Potassium Channel). Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes. Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Intravenous immunoglobulin

This is a blood product containing antibodies from thousands of healthy donors.

DRUG

Placebo

This is the control, or sham, treatment

DRUG

Rituximab

Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation

Locations (10)

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