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)
University of Cambridge
70 participants
Nov 1, 2017
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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
Interventions
This is a blood product containing antibodies from thousands of healthy donors.
This is the control, or sham, treatment
Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03194815