Imperial College London
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ProfessorThomasBarnes

Faculty of Medicine, Department of Brain Sciences

Emeritus Professor of Clinical Psychiatry
 
 
 
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Contact

 

t.r.barnes

 
 
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Location

 

Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Lennox:2019:10.1186/s13063-019-3336-1,
author = {Lennox, B and Yeeles, K and Jones, PB and Zandi, M and Joyce, E and Yu, L-M and Tomei, G and Pollard, R and Vincent, S-A and Shimazaki, M and Cairns, I and Dowling, F and Kabir, T and Barnes, TRE and Hughes, AL and Hosseini, AA and Harrower, T and Buckley, C and Coles, A},
doi = {10.1186/s13063-019-3336-1},
journal = {Trials},
title = {Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2)},
url = {http://dx.doi.org/10.1186/s13063-019-3336-1},
volume = {20},
year = {2019}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundEvidence is conflicting about a causal role of inflammation in psychosis and, specifically, regarding antibodies binding to neuronal membrane targets, especially N-methyl-D-aspartate receptors. NMDAR, LGI1 and GABA-A antibodies were found more prevalent in people with psychosis than in healthy controls. We aim to test whether these antibodies are pathogenic and may cause isolated psychosis. The SINAPPS2 phase IIa double-blinded randomised controlled trial will test the efficacy and safety of immunoglobulin and rituximab treatment versus placebo for patients with acute psychosis symptoms as added to psychiatric standard of care.MethodsWe will screen approximately 2500 adult patients with acute psychosis to identify 160 with antibody-positive psychosis without co-existing neurological disease and recruit about 80 eligible participants to the trial in the period from September 2017 to September 2021 across the UK. Eligible patients will be randomised 1:1 either to intravenous immunoglobulin (IVIG) followed by rituximab or to placebo infusions of 1% albumin followed by 0.9% sodium chloride, respectively. To detect a time-to-symptomatic-recovery hazard ratio of 0.322 with a power of 80%, 56 participants are needed to complete the trial, allowing for up to 12 participants to drop out of each group.Eligible patients will be randomised and assessed at baseline within 4 weeks of their eligibility confirmation. The treatment will start with IVIG or 1% albumin placebo infusions over 2–4 consecutive days no later than 7 days from baseline. It will continue 4–5 weeks later with a rituximab or sodium chloride placebo infusion and will end 2–3 weeks after this with another rituximab or placebo infusion. The primary outcome is the time to symptomatic recovery defined as symptomatic remission sustained for at least 6 months on the following Positive and Negative Syndrome Scale items: P1, P2, P3, N1, N4, N6, G5 and G9. Participants will be followed for 12
AU  - Lennox,B
AU  - Yeeles,K
AU  - Jones,PB
AU  - Zandi,M
AU  - Joyce,E
AU  - Yu,L-M
AU  - Tomei,G
AU  - Pollard,R
AU  - Vincent,S-A
AU  - Shimazaki,M
AU  - Cairns,I
AU  - Dowling,F
AU  - Kabir,T
AU  - Barnes,TRE
AU  - Hughes,AL
AU  - Hosseini,AA
AU  - Harrower,T
AU  - Buckley,C
AU  - Coles,A
DO  - 10.1186/s13063-019-3336-1
PY  - 2019///
SN  - 1745-6215
TI  - Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2)
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-019-3336-1
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000470786500005&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3336-1
UR  - http://hdl.handle.net/10044/1/76708
VL  - 20
ER  -
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