A trial to investigate the efficacy and safety of immunotherapy (intravenous immunoglobulins and rituximab) in patients with antibody-associated psychosis, compared to placebo (SINAPPS2)
- Conditions
- Antibody associated PsychosisTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2016-000118-31-GB
- Lead Sponsor
- Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 80
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)