A randomized, double-blinded, placebo-controlled study of Rituximab in patients with Psychosis and/or Obsessive Compulsive Disorder, with an indication of immune system involvement (Ra-P-OCD)

New European consensus guidelines provide a comprehensive review of the evidence that clinical “red flags”, disease trajectory and objective findings can be combined to indicate autoimmune processes in patients with severe psychiatric states, even in the absence of a known autoantibody. The investigations also aid in revealing other types of treatable comorbidites.

The recomended investigations are however poorly implemented in Sweden.

There is an acute need to educate psychiatrists on these new disease mechanisms and implement the guidelines in a cohesive multi-disciplinary approach to psychiatry and develop objective disease markers. Standard psychiatric evaluations are a very poor base for patient selection for immunotherapy studies.

An ongoing single center 16-month randomized, double-blinded, placebo-controlled cross-over trial repurposes Rituximab. The design maximizes the potential for evidence and quality of the longitudinal biological data generated.

The planing project is essential before expanding the trial to other centers to capture patients with subjective and objective indications of immunological involvement and minimize potential risks. Patients and clinical experts are effectively engaged.

This improved clinical investigations and the proposed trial can catalyse a paradigm shift in clinical psychiatry investigations and provide new tools by which to biologically stratify patients with immune-induced mental illness for predictable treatment responses.