A study of Rituximab treatment in patients with Psychosis an/or Obsessive Compulsive Disorder, with a suspected involvement of the immune system

Phase 1

• Conditions: Obsessive-compulsive disorder (OCD) or Obsessive-compulsive behaviour (OCB) or psychotic disorder (PD) in which there is an indication of immune system involvement.; MedDRA version: 20.0 Level: PT Classification code 10029898 Term: Obsessive-compulsive disorder System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2019-000256-33-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

General criteria

1.Diagnostic criteria: ICD 10 at least one of the following ICD 10 diagnoses:
a.Obsessive-compulsive disorder ICD F42 or
b.Obsessive-compulsive behavior ICD R46.81 AND/OR
c.Schizophrenia, delusional, and other non-mood psychotic disorders, namely
?F20 Schizophrenia
?F22 Delusional disorders
?F23 Brief psychotic disorder
?F25 Schizoaffective disorders
?F28 Other psychotic disorder not due to a substance or known physiological condition
?F29 Unspecified psychosis not due to a substance or known physiological condition
2.Age: 18-55
3.Severity: Clinical Global impression (CGI): Minimum score of 4 = Moderately ill”
4.Swedish or English proficiency
5.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
6.Medication has been unchanged for at least one month prior to study start
7.Signed informed consent
8.Use of adequate contraception
9.Radiological evidence of brain atrophy and scarring are absent
10.The clinical picture indicates active inflammatory activity (see specific criteria below), potential for rehabilitation and time from disease and/or episode debut is no longer than 10 years.

Specific criteria
11.Acute (<12 weeks) or atypical debut, or episodes of any of the following:
a.Symptoms of encephalopathy:
?psychotic symptoms, including hallucinations, delusions, paranoia, disorganized speech, disorganized behavior
?agitation, confusion
?sudden change in personality as perceived by the social environment
?drowsiness
?loss of functions in daily life
?cognitive problems (memory, speech, learning)
?emotional dysregulation
b.Focal neurological symptoms, e.g.
?ataxia, dystonia, myoclonus, sensory losses, paresthesia
c.Psychomotor anomaly,
?e.g. retardation, catatonic symptoms, parkinsonism
d.Loss of drive (sleep, appetite, libido, motivation)
e.Obsessions, compulsions (OCD/OCB),
f.Hypo- or hypervigilance (for e.g sounds, emotions, other peoples´ or own behavior)
g.Sleeping disorders,

AND

12.At least one of the following criteria:
a.Prodromal phase with infection or symptoms of infection (fever, malaise, etc)
b.Clinical improvement of psychiatric symptoms after treatment with anti-inflammatory medications other than antibody therapy (such as steroids, NSAIDs IVIG, plasmaphereses), or antibiotics
c.Radiological evidence of neuroinflammation (MR)
d.EEG pathology or witnessed epileptic seizure
e.Biochemical evidence of inflammation, autoimmunity or blood-brain barrier dysfunction in blood or CSF samples, such

Exclusion Criteria

13.Concomitant malignancies or previous malignancies within the last five years
14.Cannot comply with vaccination recommendations
15.History of severe allergic or anaphylactic reactions in conjunction with prior treatment with monoclonal antibodies
16.Prior antibody therapy including Rituximab (MabThera®/Rituxan®)
17.Patient has been treated with clozapine (which may have immunosuppressant effect), systemic corticosteroids or IVIG within 60 days prior to screening visit
18.Prior treatment with immunosuppressant medications (not including systemic corticosteroids and IVIG) for other medical condition
19.History of or positive screening for HIV, Tuberculosis, Hepatitis B and/or Hepatitis C (ever)
20.Heart disease such as previous heart attack, arrhythmia or heart failure, coronary insufficiency
21.Current drug, alcohol, or chemical abuse
22.Pregnancy at any time during the study
23.Known significant bacterial/viral/fungal infections at infusion date
24.Diagnosis of well-established neuroinflammatory disease such as MS (ICD codes G00–G09, G35–G37) or SLE (M32)
25.Tested positive for autoantibodies in serum or CSF associated to known and treatable neuroinflammatory disease (such as neuroborreliosis, treatable autoimmune encephalitis). Patients having completed recommended treatment without significant improvement may still be included in this study.
26.History of any illness that in the opinion of the investigator may jeopardize the ability of the patient to participate in the study.
27.Patient is enrolled in another medical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified