Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2025-12-24 @ 4:00 PM
NCT ID:
NCT04323566
Eligibility Criteria:
INCLUSION CRITERIA
General criteria
1. Diagnostic criteria: ICD 10 at least one of the following ICD 10 diagnoses:
1. Obsessive-compulsive disorder ICD F42 or
2. Obsessive-compulsive behavior ICD R46.81 AND/OR
3. 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:
1. 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
2. Focal neurological symptoms, e.g. ataxia, dystonia, myoclonus, sensory losses, paresthesia
3. Psychomotor anomaly, e.g.retardation, catatonic symptoms, parkinsonism
4. Loss of drive (sleep, appetite, libido, motivation)
5. Obsessions, compulsions (OCD/OCB),
6. Hypo- or hypervigilance (for e.g sounds, emotions, other peoples´ or own behavior)
7. Sleeping disorders,
AND
12. At least one of the following criteria:
1. Prodromal phase with infection or symptoms of infection (fever, malaise, etc)
2. Clinical improvement of psychiatric symptoms after treatment with anti-inflammatory medications other than antibody therapy (such as steroids, NSAIDs IVIG, plasmaphereses), or antibiotics
3. Radiological evidence of neuroinflammation (MR)
4. EEG pathology or witnessed epileptic seizure
5. Biochemical evidence of inflammation, autoimmunity or blood-brain barrier dysfunction in blood or CSF samples, such as one of the following:
presence of oligoclonal bands
elevated CSF cell count
elevated albumin quotient, or elevated albumin in CSF
elevated Immunoglobulin G (IgG) ratio
elevated levels of neurofilament
6. Patient history of autoimmune disorder not associated with neuroinflammation, such as type 1 diabetes, rheumatoid arthritis, Sjögren´s syndrome, inflammatory bowel disease (IBD, comprising Crohn´s disease and ulcerative colitis), celiac disease, Grave´s disease, Hashimoto's thyroiditis
7. Biochemical indication of autoimmunity such as elevated serum anti-thyroid peroxidase (TPO) antibody, antinuclear antibody (ANA), anti-neutrophil cytoplasmic antibody (ANCA), rheumatoid factor (RF) or glutamic acid decarboxylase (GAD) antibodies, PANDAS panel with relationship to symptom development.
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 chronical significant bacterial/viral/fungal infections at infusion date
24. Diagnosis of well-established neuroinflammatory disease such as Multiple Sclerosis (MS) (ICD codes G00-G09, G35-G37) or systemic lupus erythematosus (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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04323566
Study Brief:
Protocol Section:
NCT04323566