2024-518259-49-00招募中3 期
Phase III randomized, multicenter open label clinical trial to evaluate the efficacy of immunomodulatory therapy in case of psychiatric disorders with proven dysimmunity. TIM-DePisT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: For adult and adolescent patients (who reached 17 years old at step 1 inclusion visit) : 20% decrease from baseline of BPRS-E scale. For children patients aged between 6 and 16 years old at step 1 inclusion visit: 25% decrease from baseline of ABC (Aberrant Behavior Checklist) scale.
研究概览
简要总结
To evaluate the efficacy at 3 months of immunotherapy for patients with psychotic symptoms and proven auto-immunity added to ongoing psychiatric care (with or without standard psychotropic treatment).
研究设计
- 分配方式
- Randomized
- 主要目的
- Step 2 : therapeutic period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •For step 1 : For Adult and Adolescent (who reached 17 years old): First acute or relapse of psychotic disorders defined by the PANSS scale with or without standard pharmacological treatment.
- •For Step 1 : For Children: Child aged between 6 and 16 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
- •Informed consent concerning the step 1 of the patient or his legal representatives.
- •For step 2 : Patient for whom inclusion criteria for step 1 of the trial are present with or without standard pharmacological treatment.
- •For step 2 : Biological diagnosis of pathogenic CNS autoantibodies in the blood.
- •For step 2 : MDC scale score >3 is required for inclusion in step
- •For step 2, Normal ECG in case of previous heart disease.
- •For step 2, Informed consent concerning the step 2 of the patient or his legal representatives
- •For step 2, Effective contraception for women of childbearing potential during the clinical trial and for at least 12 months after the last rituximab administration.
排除标准
- •For the first step of the clinical trial (diagnostic) : Developmental disorder related to a genetic disease.
- •For the second step: Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state).
- •for the second step: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- •for the second step: Pregnant or breastfeeding women at the randomization visit.
- •for the second step: 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.
- •for the second step: Previous treatment with rituximab in the past 12 months.
- •for the second step: Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
- •for the second step: Recent vaccination with live viral vaccine (within 3 months).
- •for the second step: Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.
- •For the first step :Co-existing disorder of severe neurological disease.
- •For the first step :Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
- •For the first step: Pregnant or breastfeeding women.
- •For the second step of the clinical trial (Intervention): Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
- •For the second step : Blood platelets < 75x109/L
- •For the second step: Neutrophils < 1.5x109/L
- •For the second step: Neoplastic pathology
- •For the second step: Hepatitis B or HIV infection
结局指标
主要结局
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: For adult and adolescent patients (who reached 17 years old at step 1 inclusion visit) : 20% decrease from baseline of BPRS-E scale. For children patients aged between 6 and 16 years old at step 1 inclusion visit: 25% decrease from baseline of ABC (Aberrant Behavior Checklist) scale.
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: For adult and adolescent patients (who reached 17 years old at step 1 inclusion visit) : 20% decrease from baseline of BPRS-E scale. For children patients aged between 6 and 16 years old at step 1 inclusion visit: 25% decrease from baseline of ABC (Aberrant Behavior Checklist) scale.
次要结局
- for adults and adolescents : general functioning measurement with the GAF scale
- for adults and adolescents : cognitive assessment thanks to the MOCA scale
- for adults and adolescents : neurologic evaluation with the 2 scales KREBS and BUSH
- for adults and adolescents : psychotic disorders measurement with the PANSS scale
- for adults and adolescents : assessment of the evolution of depressive and manic disorders thanks to the MADRS and YMRS scales.
- for children (aged between 6 and 16 years old at step 1 inclusion visit) :psychotic disorders measurement with the PANSS scale
- for children : assessment of the evolution of depressive and manic disorders thanks to the CDRS and YMRS scales
- for children : neurologic evaluation BUSH scale
- for all: Persistence rate of autoimmunity in psychiatric disorder at baseline for all participants to the Step 1 of the trial
- for all: Remission of psychiatric symptoms in each group of participants to the Step 2 of the trial, at M1, M6 and M12
- for all: Evaluation of severity and improvement with CGI-S and CGI-I
- for all: Level of autoimmune Abs at 3 months in each group of participants to the Step 2 of the trial
- for all: Frequency and nature of serious and non-serious adverse events as well as infections in each arm.
研究者
Coordinating investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (9)
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