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IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2
Sponsor: University of Cambridge
Summary
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.
Official title: A Randomised Phase II Double-blinded Placebo-controlled Trial of Intravenous Immunoglobulins and Rituximab in Patients with Antibody-associated Psychosis (SINAPPS2)
Key Details
Gender
All
Age Range
16 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2017-11-01
Completion Date
2027-03-31
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
Intravenous immunoglobulin
This is a blood product containing antibodies from thousands of healthy donors.
Placebo
This is the control, or sham, treatment
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