drugset / Trial / NCT03194815
IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-11-01
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 1 g | — |