Clinical Trials Logo
  1. Home
  2. Psychosis
  3. NCT03194815

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 — SINAPPS2  

Psychosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03194815
Study type Interventional
Source University of Cambridge
Contact Alastdair Coles, PhD FRCP
Phone +44 (0)1223 762016
Email ajc1020@medschl.cam.ac.uk
Status Recruiting
Phase Phase 2
Start date November 1, 2017
Completion date March 31, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04929938 - Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients N/A
Recruiting NCT05863572 - Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda N/A
Completed NCT04277585 - Improving Access to Early Psychosis Coordinated Specialty Care N/A
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Not yet recruiting NCT05358457 - Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Completed NCT02895269 - COllaborative Shared Care to IMprove Psychosis Outcome N/A
Recruiting NCT02622048 - Understanding and Helping Families: Parents With Psychosis N/A
Completed NCT02653729 - Cbt for Psychosis and Affect on Psychosis Symptoms Phase 2
Completed NCT02733575 - Compassion Focused Therapy for Distressing Experiences N/A
Completed NCT02531243 - Computer-Aided Learning for Managing Stress N/A
Not yet recruiting NCT02244970 - Mindfulness RCT for Early Psychosis N/A
Enrolling by invitation NCT01364818 - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment N/A
Withdrawn NCT00786318 - Ziprasidone vs Standard Therapy for Agitated Patients in the ED Phase 4
Recruiting NCT00722163 - A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis Phase 0