IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2
SINAPPS2
A Randomised Phase II Double-blinded Placebo-controlled Trial of Intravenous Immunoglobulins and Rituximab in Patients with Antibody-associated Psychosis (SINAPPS2)
1 other identifier
interventional
70
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2017
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
March 30, 2025
March 1, 2025
9.4 years
February 2, 2017
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to start of symptomatic recovery (symptomatic remission sustained for at least 6 months)
remission defined as Positive and Negative Syndrome Scale (PANSS) score 3 or less on PANSS items P1, P2, P3, N1, N4, N6, G5 and G9 sustained for 6 months
up to 18 months
Secondary Outcomes (11)
Time to first treatment response (whether sustained or not)
up to 18 months
Relapse rate
18 months
Number of adverse effects
18 months
Proportion of patients reaching 20% reduction in PANSS total score
12 months
Proportion of patients reaching 30% reduction in PANSS total score
12 months
- +6 more secondary outcomes
Study Arms (2)
Intravenous immunoglobulin and Rituximab
ACTIVE COMPARATOROne 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.
Placebo
PLACEBO COMPARATOROne 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.
Interventions
This is a blood product containing antibodies from thousands of healthy donors.
Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cambridgelead
- University of Oxfordcollaborator
Study Sites (10)
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, NW1 2PG, 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
Related Publications (1)
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.
PMID: 31174586DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alasdair Coles, PhD FRCP
University of Cambridge, UK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Revd. Prof. Alasdair Coles, Chief Investigator
Study Record Dates
First Submitted
February 2, 2017
First Posted
June 21, 2017
Study Start
November 1, 2017
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
March 30, 2025
Record last verified: 2025-03