Rituximab Treatment for Psychosis And/or Obsessive Compulsive Disorder with Probable Immune Syste… (NCT04323566) | Clinical Trial Compass
By InvitationPhase 2
Rituximab Treatment for Psychosis And/or Obsessive Compulsive Disorder with Probable Immune System Involvement
Sweden40 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Diagnostic criteria: ICD 10 at least one of the following ICD 10 diagnoses:
✓. Schizophrenia, delusional, and other non-mood psychotic disorders, namely
✓. Age: 18-55
✓. Severity: Clinical Global impression (CGI): Minimum score of "4 = Moderately ill"
✓. Swedish or English proficiency
✓. The patient has tried at least 2 standard psychiatric medications at maximal tolerable or maximal recommended dosage for his/her current condition over a period of 6 months, but has not improved significantly
Exclusion criteria
✕3. Concomitant malignancies or previous malignancies within the last five years
✕4. Cannot comply with vaccination recommendations
✕5. History of severe allergic or anaphylactic reactions in conjunction with prior treatment with monoclonal antibodies
✕6. Prior antibody therapy including Rituximab (MabThera®/Rituxan®)
✕7. Patient has been treated with clozapine (which may have immunosuppressant effect), systemic corticosteroids or IVIG within 60 days prior to screening visit
✕8. Prior treatment with immunosuppressant medications (not including systemic corticosteroids and IVIG) for other medical condition
✕9. History of or positive screening for HIV, Tuberculosis, Hepatitis B and/or Hepatitis C (ever)
✕0. Heart disease such as previous heart attack, arrhythmia or heart failure, coronary insufficiency