Study of Immunotherapy in Autoantibody Positive Psychosis
SINAPPS-1
An Unblinded Study of the Feasibility of Plasmapheresis or Intravenous Immunoglobulin, Combined With Corticosteroids, in Patients With Acute Psychosis Associated With Anti-neuronal Membrane Auto-antibodies
1 other identifier
interventional
10
1 country
5
Brief Summary
Psychosis is a mental health problem that causes people to perceive or interpret things differently from those around them, often involving hallucinations or delusions. Psychosis and schizophrenia are common disorders which predominantly affect younger adults. Recently, the investigators discovered that 5-10% of people with psychosis have antibodies in the blood that are capable of targeting the surface of brain cells, specific to the N-methyl-D-aspartate (NMDA) receptor or voltage gated potassium channel complex, which the investigators believe may be causing the problem. Those positive for antibodies may have a problem with their immune system and this may prevent their brain from working normally. This trial aims to test the feasibility of removing or reducing the antibodies in patients' blood, using immunotherapy, and see if this improves symptoms of psychosis. Immunotherapy in this feasibility study will involve giving all patients steroid tablets and half of them will also receive a drug called "intravenous immunoglobulin" whereas the other half will have a procedure called "plasma exchange". The feasibility study is designed to identify which method of immunotherapy is most suitable for use in this patient population. Results from this will inform on the methodology used for a proposed larger randomised control trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Aug 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 19, 2018
February 1, 2018
2 years
May 13, 2015
February 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients who start on allocated care pathway within 2 weeks of randomisation.
percentage of recruited patients who start on allocated care pathway within 2 week from randomisation
2 weeks
Study Arms (2)
Intravenous Immunoglobulin (IVIG)
ACTIVE COMPARATORIntravenous Immunoglobulin IVIG is a pooled blood product from 3000-100,000 human blood donors with direct immunomodulatory effects. IVIG will be given at a dose of 2g/kg over 4 days. Dosing at 2g/kg is established in neurological disorders, with limited evidence that lower doses are less effective although adequate dosing studies have not been performed.
Plasma Pheresis / Plasma Exchange (PLEX)
ACTIVE COMPARATORPlasma Exchange (PLEX) is a procedure in which the subject's blood is passed through a medical device which separates out plasma from the other blood components, and replaces the plasma with albumin or plasma or other colloid. PLEX therefore removes circulating pathogenic antibodies, and its use was first reported in myasthenia gravis in 1976, and furthermore therapeutic benefit after PLEX supports an antibody mediated pathogenesis of disease. In PLEX, 200-250 mL plasma per kg body weight is exchanged typically over 7-14 days using 5% albumin as replacement, often at alternate days which increases the amount of immunoglobulin removed due to equilibrium effects . PLEX modality (centrifugation or filtration), type of anticoagulation, and dose scheduling will be determined by local centre practice
Interventions
PLEX is a procedure in which the subject's blood is passed through a medical device which separates out plasma from the other blood components, and replaces the plasma with albumin or plasma or other colloid. PLEX therefore removes circulating pathogenic antibodies, and furthermore therapeutic benefit after PLEX supports an antibody mediated pathogenesis of disease. In PLEX, 200-250 mL plasma per kg body weight is exchanged typically over 7-14 days using 5% albumin as replacement, often at alternate days which increases the amount of immunoglobulin removed due to equilibrium effects. PLEX modality (centrifugation or filtration), type of anticoagulation, and dose scheduling will be determined by local centre practice.
Active Comparator: Intravenous Immunoglobulin (IVIG) IVIG is a pooled blood product from 3000-100,000 human blood donors with direct immunomodulatory effects. IVIG will be given at a dose of 2g/kg over 4 days. Dosing at 2g/kg is established in neurological disorders, with limited evidence that lower doses are less effective although adequate dosing studies have not been performed.
Eligibility Criteria
You may qualify if:
- Acute psychosis
- Serum and/or Cerebrospinal flud (CSF) neuronal membrane autoantibodies (including N-methyl-D-aspartate receptor (NMDAR), Voltage gated potassium channel (VGKC), Leucine-rich, glioma inactivated 1,(LGI1), gamma-aminobutyric acid (GABA \[A\]) receptor)
- Positive and Negative Syndrome Scale (PANSS) \>4 on items of positive psychotic symptoms
You may not qualify if:
- current symptoms greater than 2 years duration,
- co-existing severe neurological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cambridgelead
- University of Oxfordcollaborator
- Stanley Medical Research Institutecollaborator
- McPin Foundationcollaborator
Study Sites (5)
University Hospitals Birmingham
Birmingham, United Kingdom
Cambridge University Hospitals
Cambridge, United Kingdom
Nottingham University Hospitals
Nottingham, United Kingdom
Oxford University Hospitals
Oxford, United Kingdom
University Hospitals Southampton
Southampton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alasdair Coles, 01223 762016
ajc1020@medschl.cam.ac.uk
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- open label
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Rev Alasdair Coles, Principal Investigator
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 20, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2017
Study Completion
December 1, 2017
Last Updated
February 19, 2018
Record last verified: 2018-02