临床试验/2024-518391-31-00

2024-518391-31-00尚未招募2 期

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.

Region Uppsala1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2024年11月5日最近更新: 2024年11月14日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 40
试验地点: 1
主要终点: The clinical efficacy of Rituximab treatment will be evaluated by calculating the average difference between BPRS scores at baseline and main-evaluation (8-month) and comparing it between the treatment-first and the placebo-first group.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

入排标准

年龄范围: 18 years 至 64 years（18-64 Years）
接受健康志愿者: 是

入选标准

•Patients to be included in this study meet the criteria for at least one of the following ICD 10 CM diagnoses: o Obsessive-compulsive disorder ICD F42 or o Obsessive-compulsive behavior ICD R46.81 o 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
•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.
•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
•AND 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 as one of the following:  presence of oligoclonal bands  elevated CSF cell count  elevated albumin quotient, or elevated albumin in CSF  elevated IgG ratio  elevated levels of neurofilament f. 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 g. Biochemical indication of autoimmunity such as elevated serum anti-TPO, ANA, ANCA, RF or GAD antibodies, PANDAS panel with relationship to symptom development.
•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
•Medication has been unchanged for at least one month prior to study start
•Signed informed consent
•Use of adequate contraception
•Radiological evidence of brain atrophy and scarring are absent

排除标准

•Concomitant malignancies or previous malignancies within the last five years
•Pregnancy at any time during the study
•Known chronical significant bacterial/viral/fungal infections
•Diagnosis of well-established neuroinflammatory disease such as MS (ICD codes G00–G09, G35–G37) or SLE (M32)
•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.
•History of any illness that in the opinion of the investigator may jeopardize the ability of the patient to participate in the study.
•Patient is enrolled in another medical trial.
•Cannot comply with vaccination recommendations
•History of severe allergic or anaphylactic reactions in conjunction with prior treatment with monoclonal antibodies
•Prior antibody therapy including Rituximab (MabThera®/Rituxan®)
•Patient has been treated with clozapine (which may have immunosuppressant effect), systemic corticosteroids or IVIG within 60 days prior to screening visit
•Prior treatment with immunosuppressant medications (not including systemic corticosteroids and IVIG) for other medical condition
•History of or positive screening for HIV, Tuberculosis, Hepatitis B and/or Hepatitis C (ever)
•Heart disease such as previous heart attack, arrhythmia or heart failure, coronary insufficiency
•Current drug, alcohol, or chemical abuse

结局指标

主要结局

The clinical efficacy of Rituximab treatment will be evaluated by calculating the average difference between BPRS scores at baseline and main-evaluation (8-month) and comparing it between the treatment-first and the placebo-first group.

次要结局

1. The amelioration in psychiatric symptomatology will be assessed by following the psychiatric rating scales: o CGI o WHODAS, o EQ-VAS, o Y-BOCS o BFCS
2. Improvement in executive functions, will be assessed by following neuropsychiatric tests: o Neuropsychological tests o Mismatch negativity
3. The amelioration of neurological symptoms will be assessed by performing complete, video-recorded neurological exams. This procedure is described in section 11.
4. The longevity of psychiatric, neurological and executive improvements will be examined by the psychiatric ratings scales named in 1. and blood samples every 4 months up to 16 months, and in addition to that a thorough neurological exam, the executive tests named in 2. and CSF samples every 8 months up to 16 months.
5. The safety of Rituximab treatment will be assessed by adverse events monitoring and questionnaires described in detail in section 12.

研究者

发起方

Region Uppsala

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Janet Cunningham

Scientific

Region Uppsala

研究点 (1)

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