Phase III Randomized, Multicenter Open Label Study to Evaluate the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 9
- 主要终点
- Minor patients : the remission of psychiatric symptoms at 3 months
研究概览
简要总结
This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac).
详细描述
This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac). The aim is to assess the clinical efficacy of this treatment associated with the usual recommended psychotropic treatment. To meet this objective, we will use, via a National Center for Scientific Research (CNRS) Research laboratory in Bordeaux, a very sensitive diagnostic platform to detect and demonstrate the pathogenesis of antibodies in patient serum. This platform is operational only within the framework of validation of the results by the reference center for neurological autoimmune diseases in Lyon
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Adult: First acute or relapse of psychotic disorders defined by the BPRS-E scale with or without standard pharmacological treatment.
- •For Children: Child over 6 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
- •Biological diagnosis of pathogenic CNS autoantibodies in the blood.
- •MDC scale score >3 is required for inclusion in step
- •Normal ECG in case of previous heart disease.
- •Informed consent of the patient or his legal representatives.
- •Effective contraception for women of childbearing potential during the study and for at least 12 months after the last rituximab administration.
排除标准
- •Developmental disorder related to a genetic disease.
- •Co-existing disorder of severe neurological disease.
- •Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
- •Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
- •Blood platelets < 75x109/L
- •Neutrophils < 1.5x109/L
- •Neoplastic pathology,
- •Hepatitis B or HIV infection,
- •Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state).
- •Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- •Pregnant or breastfeeding women
- •Currently receiving an investigational drug or received an investigational drug or device within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening.
- •Previous treatment with rituximab in the past 12 months.
- •Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
- •Recent vaccination with live viral vaccine (within 3 months).
- •Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.
研究组 & 干预措施
experimental group
immunomodulatory treatment by rituximab, 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days), added to stable ongoing psychiatric care (with or without standard treatment as usual ( i.e. antipsychotic, mood stabiliser, antidepressant and/or anxiolytic)). The rituximab is the best immunomodulatory treatment recommended for neurologic encephalitis.
干预措施: immunomodulatory treatment by rituximab (Drug)
结局指标
主要结局
Minor patients : the remission of psychiatric symptoms at 3 months
时间窗: 3 months after randomization
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: - For patients \<18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Adult patients : the remission of psychiatric symptoms at 3 months
时间窗: 3 months after randomization
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: - For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).
次要结局
- Adult Patients : the remission of psychiatric symptoms at 12 months(12 months after randomization)
- Adult Patients : the remission of psychiatric symptoms at 6 months(6 months after randomization)
- Minor patients : the remission of psychiatric symptoms at 1 month(1 month after randomization)
- Minor patients : Child behaviour check list (CBCL) /6-18 scale at 1 month(1 month after randomization)
- Minor patients : the remission of psychiatric symptoms at 12 months(12 months after randomization)
- Adult patients : general functioning at 1 month(1 month after randomization)
- Adult patients : general functioning at 12 months(12 months after randomization)
- Minor patients : Child behaviour check list (CBCL) /6-18 scale at 12 months(12 months after randomization)
- Adult patients : general functioning at 6 months(6 months after randomization)
- Minor patients : Child behaviour check list (CBCL) /6-18 scale at 3 months(3 months after randomization)
- Adult Patients : the remission of psychiatric symptoms at 1 month(1 month after randomization)
- Minor patients : the remission of psychiatric symptoms at 6 months(6 months after randomization)
- Adult patients : general functioning at 3 months(3 months after randomization)
- Minor patients : Child behaviour check list (CBCL) /6-18 scale at 6 months(6 months after randomization)