Actively Recruiting
IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2
Led by University of Cambridge · Updated on 2025-03-30
70
Participants Needed
10
Research Sites
491 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute psychosis longer than 2 weeks, either first episode or relapse after remission (remission means mild or no symptoms for at least 6 months)
- Presence of serum or cerebrospinal fluid neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1, and others)
- Psychosis symptoms scoring 4 or more on at least one of these PANSS items: P1, P2, P3, N1, N4, N6, G5, or G9
You will not qualify if you...
- Current psychosis episode lasting more than 24 months
- Having a severe neurological disease at the same time
- Signs of current acute encephalopathy
- Hepatitis or HIV infection, or pregnancy
- Contraindications to any trial medication
- Currently enrolled in another clinical trial involving investigational medicinal products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Cambridge University Hospitals NH Foundation Trust
Cambridge, United Kingdom
Actively Recruiting
2
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom
Actively Recruiting
3
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Actively Recruiting
4
The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom
Actively Recruiting
5
University College London Hospitals Nhs Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
6
King's College Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
7
Salford Royal NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
8
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Actively Recruiting
9
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
10
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Actively Recruiting
Research Team
A
Alastdair Coles, PhD FRCP
CONTACT
B
Belinda Lennox, DM MRCPsych
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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