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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03194815
Other study ID # SINAPPS 2
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 1, 2017
Est. completion date March 31, 2026

Study information

Verified date January 2024
Source University of Cambridge
Contact Alastdair Coles, PhD FRCP
Phone +44 (0)1223 762016
Email ajc1020@medschl.cam.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Investigators propose a randomised double-blinded placebo-controlled trial to test the hypothesis that immunotherapy is an effective treatment of antibody-associated psychosis, either first episode of psychosis or relapse following previous remission. Immunotherapy for the trial consists of one cycle of intravenous immunoglobulin (IVIG: 2g/kg over days 1-4) followed by two infusions of 1g rituximab (at day 28-35, and then 14 days after the first infusion). The rationale for this regime is that it combines a rapid-action treatment (IVIG) to induce remission with a longer-action therapy (rituximab) to maintain remission. It is based on a protocol where elimination of circulating antibodies is the treatment goal, namely "desensitisation" of potential transplant patients who have multiple anti-HLA antibodies capable of inducing hyperacute rejection and also being tested in various trials on clinicaltrials.gov (NCT00642655, NCT01178216, and NCT01502267). Blinding is required to minimise placebo responses in a trial based on symptomatology.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intravenous immunoglobulin
This is a blood product containing antibodies from thousands of healthy donors.
Placebo
This is the control, or sham, treatment
Rituximab
Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation

Locations

Country Name City State
United Kingdom 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 King's College Hospital NHS Foundation Trust London
United Kingdom University College London Hospitals 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

Sponsors (2)

Lead Sponsor Collaborator
University of Cambridge University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time to first treatment response (whether sustained or not) Treatment response defined as score of 3 or less on each of the following PANSS items: P1, P2, P3, N1, N4, N6, G5, and G9. up to 18 months
Secondary Relapse rate Relapse rate is defined as a score 4 or more on PANSS items P1, P2, P3, N1, N4, N6, G5, and G9. 18 months
Secondary Number of adverse effects total number of patient reported adverse effects 18 months
Secondary Proportion of patients reaching 20% reduction in PANSS total score 20% reduction in the PANSS total score (all PANNS items included) 12 months
Secondary Proportion of patients reaching 30% reduction in PANSS total score 30% reduction in the PANSS total score (all PANNS items included) 12 months
Secondary Proportion of patients reaching 40% reduction in PANSS total score 40% reduction in the PANSS total score (all PANNS items included) 12 months
Secondary Changes in the Clinical Global Impression Scale in Schizophrenia (CGI-Schizophrenia) Change in CGI-Schizophrenia scores from baseline to month 12 12 months
Secondary Changes in the Young Mania Rating Scale (YMRS) Change in YMRS total score from baseline to month 12 12 months
Secondary Changes in the Antipsychotic Non-Neurological Side-Effects Rating Scale (ANNSERS) Change in ANNSERS total score from baseline to month 12 12 months
Secondary Changes in the Brief Assessment of Cognition in Schizophrenia (BACS) Change in BACS scores from baseline to month 12 12 months
Secondary Changes in the Global Assessment of Functioning scale (GAF) Change in the GAF score from baseline to month 12 12 months
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