Rituximab Treatment for Psychosis And/or Obsessive Compulsive Disorder with Probable Immune System Involvement

Summary

The primary objective for this study is to evaluate whether Rituximab as compared to placebo is a clinically effective treatment for a subgroup of patients suffering from psychosis and/or obsessive-compulsive disorder (OCD) or -behavior (OCB) where there is an indication of immune system involvement.

The secondary objectives of this study are

1. To assess whether Rituximab treatment (with the doses and timing described below) as compared to placebo is associated with amelioration in psychiatric symptomatology
2. To assess whether Rituximab treatment as compared to placebo is associated with improvement in executive functions
3. To assess whether Rituximab treatment as compared to placebo is associated with amelioration in neurological symptoms
4. To evaluate the longevity of psychiatric, neurological and executive improvements associated with Rituximab treatment for up to 16 months after the first infusion (i.e. 12 months after the last infusion)
5. To evaluate whether Rituximab treatment as described is safe for these patients.

The exploratory objectives of this study are

1. To assess changes in blood and cerebrospinal fluid (CSF) markers for immune activity associated with Rituximab treatment compared to placebo
2. To assess statistical associations between biological markers in blood or CSF and clinical response
3. To describe changes in somatic symptoms associated with treatment with Rituximab vs placebo for patients with initial symptoms in the questionnaires
4. To describe changes on MR and EEG associated with treatment with Rituximab vs placebo for patients with initial pathology in these examination
5. To study immune mechanisms coupled with psychiatric symptoms, possibly identifying novel biomarkers with potential for subtyping encephalopathies with immune engagement, using biobank cells, blood and CSF samples collected from the participants.

Conditions

• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Behavior
• Schizophrenia
• Delusional Disorder
• Brief Psychotic Disorder
• Schizo Affective Disorder
• Other Psychoses
• Unspecified Psychosis

Interventions

DRUG

Rituximab

Rituximab 500 mg, dissolved in 250 ml NaCl in an infusion bag, covered with non-see-through plastic * administered iv over a course of max 180 minutes * at 0 and 4 months (treatment-first arme) OR at 8 and 12 months (placebo-first arm)

Sponsors & Collaborators

• Uppsala University

  collaborator OTHER

• Uppsala University Hospital

  lead OTHER

Principal Investigators

• Janet L Cunningham, MD PhD · Uppsala University Hospital and Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2028-04-01

Completion

2028-12-01

Countries

• Sweden

Study Locations