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RECRUITING
NCT03194815
PHASE2

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

Sponsor: University of Cambridge

View on ClinicalTrials.gov

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

Interventions

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