Overview

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

Status:
Recruiting

Trial end date:
2024-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Cambridge

Collaborator:

University of Oxford

Treatments:

Antibodies
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Rituximab

Criteria

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