Antibody associated Psychosis
Conditions
Interventions
Trade Name: IVIG
Product Name: IVIG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
Concentr
Sponsors
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the trial the patient must have: • Patient or legal representative is willing and able to provide informed consent. • Acute psychosis for at least 2 weeks (defined as symptomatic on the PANSS scale by score equal to or greater than 4 on P1, G9, P3, P2, G5, N1, N4, N6). • This may either be a first episode or relapse after remission (remission defined as PANSS=3 on PANSS items P1, G9, P3, P2, G5, N1, N4, N6 for previous 6 months). • Serum or CSF neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1 and other) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: The presence of any of the following will preclude patient inclusion: • Duration of current episode of psychosis greater than 24 months. • Alternative co-existing severe neurological disease, including tumour, hippocampal sclerosis with refractory epilepsy, probable dementia with evidence of atrophy on brain imaging, moderate or severe learning disability. • Any evidence of a current acute encephalopathy (for instance coma, seizures). • Hepatitis B, Hepatitis C or HIV positivity; severe hypogammaglobulinaemia. • Previous malignancy (to be usually excluded unless agreed with CI). • Pregnant, breast feeding or inadequate contraception if female. • Hypersensitivity or absolute contra-indication to any study medication, murine proteins or excipients. • Live vaccine within last 3 months. • Previous treatment with rituximab in the past 12 months. • Severe infection and severe heart failure. • Any other medical illness or disability that, in the opinion of the investigator, would compromise effective study participation. • Concurrent enrolment in other CTIMPs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy of immunotherapy (IVIG and rituximab) in patients with acute psychosis associated with anti-neuronal membranes.;Secondary Objective: To test the safety of immunotherapy (IVIG and rituximab) of patients with acute psychosis associated with anti-neuronal membranes.;Primary end point(s): The primary outcome is time to start of remission, sustained for 6 months. Remission is defined as PANSS=3 on PANSS (Kay 1987) items P1, G9, P3, P2, G5, N1, N4, N6 for previous 6 months (Andreasen et al.2005).;Timepoint(s) of evaluation of this end point: Month 3, 6, 9, 12 (15,18) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes are time to first treatment response (whether sustained or not) and relapse rate, and number of adverse effects, serious infections, proportion of patients reaching 20%, 30% and 40% reduction in PANSS total score and changes in the following clinical rating scales: CGI, YMRS, ANNSERS, BACS, GAF.;Timepoint(s) of evaluation of this end point: Baseline to 12 months (up 18 months in some cases - the few patients entering remission after month 6, for a further 6 months) | — |
Countries
United Kingdom
Contacts
Public ContactMrs Carrie Bayliss
Cambridge University Hospitals NHS Foundation Trust
Outcome results
None listed