RecruitingPhase 2NCT03194815

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)


Sponsor

University of Cambridge

Enrollment

70 participants

Start Date

Nov 1, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether two treatments — IVIG (an infusion of antibodies from donated blood) and rituximab (a drug that depletes certain immune cells) — can help people with psychosis caused by their own immune system attacking the brain, a condition called antibody-associated or autoimmune psychosis. **You may be eligible if...** - You have had an episode of psychosis (hallucinations, delusions, or severely disorganised thinking) lasting more than 2 weeks - Blood or spinal fluid tests show specific abnormal antibodies attacking the brain (such as NMDAR or LGI1 antibodies) - Your symptoms meet a specific severity threshold on a psychiatric rating scale - This may be a first episode or a relapse after at least 6 months of remission **You may NOT be eligible if...** - Your current episode of psychosis has lasted more than 24 months - You have another severe neurological disease - You have signs of acute brain inflammation (encephalopathy) - You have active hepatitis B infection or serious liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntravenous immunoglobulin

This is a blood product containing antibodies from thousands of healthy donors.

DRUGPlacebo

This is the control, or sham, treatment

DRUGRituximab

Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation


Locations(10)

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

University College London Hospitals Nhs Foundation Trust

London, United Kingdom

King's College Hospital 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, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03194815


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