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NCT03194815Active, not recruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
70 (estimated)
First submitted
2 Feb 2017
Start date
1 Nov 2017
Primary completion date
30 Apr 2027
Lead sponsor
University of Cambridge
NCT number
NCT03194815

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 70
  • From 1 Nov 2017 to the primary completion date, 30 Apr 2027
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to any trial drug
  • Concurrent enrolment in another CTIMP

Other illness

  • Co-existing severe neurological disease
  • Hepatitis or HIV infection, pregnancy

Other

  • Current episode of psychosis greater than 24 months duration
  • Evidence of current acute encephalopathy

Who the study is looking for

  • 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.

Age in the registry: 16 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cambridge University Hospitals NH Foundation Trust
Coordinator of this site? Confirm its status		CambridgeUnited KingdomUnknown status
Royal Devon and Exeter NHS Foundation Trust
Coordinator of this site? Confirm its status		ExeterUnited KingdomUnknown status
NHS Greater Glasgow and Clyde
Coordinator of this site? Confirm its status		GlasgowUnited KingdomUnknown status
The Walton Centre NHS Foundation Trust
Coordinator of this site? Confirm its status		LiverpoolUnited KingdomUnknown status
King's College Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status		LondonUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status		LondonUnited KingdomUnknown status
Salford Royal NHS Foundation Trust
Coordinator of this site? Confirm its status		ManchesterUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
Coordinator of this site? Confirm its status		NottinghamUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status		OxfordUnited KingdomUnknown status
Sheffield Teaching Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status		SheffieldUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.