IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

Launched by UNIVERSITY OF CAMBRIDGE · Jun 19, 2017

Keywords

ClinConnect Summary

The SINAPPS2 trial is studying a treatment for people experiencing acute psychosis related to specific autoimmune conditions, which can affect the brain. This study is testing two treatments, IVIG (a type of blood product) and rituximab (a medication that helps the immune system), to see if they can help reduce symptoms and improve overall health for those affected by this condition. The trial is looking for participants who have had acute psychosis for more than two weeks and have certain autoantibodies in their blood or spinal fluid, indicating a problem with their immune system.

To be eligible, participants should be between 18 and 75 years old and should have experienced either their first episode of psychosis or a relapse after having been symptom-free for at least six months. However, those with a long-term episode of psychosis lasting over two years, severe neurological diseases, or certain infections like hepatitis or HIV cannot participate. If you join the trial, you'll receive either the treatment or a placebo (a non-active treatment) without knowing which one, to ensure unbiased results. The study aims to find out not only if the treatments are effective but also if they are safe for use in this patient group.

Gender

ALL

Eligibility criteria

• 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