IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2
NCT ID: NCT03194815
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2017-11-01
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intravenous immunoglobulin and Rituximab
One cycle of intravenous immunoglobulin (IVIG) 2g/kg over 2-5 days (days 1-5) followed by (b) two infusions of 1g rituximab (the first infusion starting between days 28-35, and the second infusion 14 days later), each with 100mg methylprednisolone.
Intravenous immunoglobulin
This is a blood product containing antibodies from thousands of healthy donors.
Rituximab
Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation
Placebo
One cycle of 0.9% saline solution over 2-5 days (days 1-5) followed by (b) two infusions of placebo solution alongside placebo pill - in equal volumes to steroid pre-medication and rituximab.
Placebo
This is the control, or sham, treatment
Interventions
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Intravenous immunoglobulin
This is a blood product containing antibodies from thousands of healthy donors.
Placebo
This is the control, or sham, treatment
Rituximab
Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
70 Years
ALL
No
Sponsors
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University of Oxford
OTHER
University of Cambridge
OTHER
Responsible Party
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Alasdair Coles
Revd. Prof. Alasdair Coles, Chief Investigator
Principal Investigators
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Alasdair Coles, PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge, UK
Locations
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Cambridge University Hospitals NH Foundation Trust
Cambridge, , United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
University College London Hospitals Nhs Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Salford Royal NHS Foundation Trust
Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Timothy Harrower, FRCP PhD
Role: primary
John Goodfellow, MRCP(Neurology), PhD
Role: primary
Saif Huda, MRCP DPhil
Role: primary
Ester Coutinho, MD, DPhil
Role: primary
Nazar Sharaf, PhD MRCP
Role: primary
Akram Hosseini, MD MRCP PhD
Role: primary
Priya D Shanmugarajah, MD
Role: primary
References
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Lennox B, Yeeles K, Jones PB, Zandi M, Joyce E, Yu LM, Tomei G, Pollard R, Vincent SA, Shimazaki M, Cairns I, Dowling F, Kabir T, Barnes TRE, Lingford Hughes A, Hosseini AA, Harrower T, Buckley C, Coles A. Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2). Trials. 2019 Jun 7;20(1):331. doi: 10.1186/s13063-019-3336-1.
Related Links
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SINAPPS Group website
Other Identifiers
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SINAPPS 2
Identifier Type: -
Identifier Source: org_study_id
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