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IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

NCT03194815 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Alasdair Coles, PhD FRCP · University of Cambridge, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194815 on ClinicalTrials.gov