IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

Sponsor
University of Cambridge
Study ID
NCT03194815
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Autoimmune Encephalitis
  • Psychosis

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 1, 2017
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intravenous immunoglobulin and Rituximab
    One cycle of intravenous immunoglobulin (IVIG) 2g/kg over 2-5 days (days 1-5) followed by (b) two infusions of 1g rituximab (the first infusion starting between days 28-35, and the second infusion 14 days later), each with 100mg methylprednisolone.
  • Placebo Comparator: Placebo
    One cycle of 0.9% saline solution over 2-5 days (days 1-5) followed by (b) two infusions of placebo solution alongside placebo pill - in equal volumes to steroid pre-medication and rituximab.

Primary Outcome Measure

Time to start of symptomatic recovery (symptomatic remission sustained for at least 6 months) [ Time Frame: up to 18 months ]

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