NCT03194815

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

A Randomised Phase II Double-blinded Placebo-controlled Trial of Intravenous Immunoglobulins and Rituximab in Patients with Antibody-associated Psychosis (SINAPPS2)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Psychosis
• Autoimmune Encephalitis

Interventions

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

Timeline

• Start date: 2017-11-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2017-06-21
• Last updated: 2025-03-30

Locations

10 sites across 1 country: United Kingdom