ISRCTN11177045进行中（未招募）2 期
A randomised phase II double-blinded placebo-controlled trial of intravenous immunoglobulins and rituximab in patients with antibody-associated psychosis (SINAPPS2)
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 80 人开始时间: 2017年5月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31174586 protocol (added 10/06/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Acute psychosis >2 weeks. This may either be the first episode or relapse after remission (remission defined as PANSS=3 on PANSS items P1, G9, P3, P2, G5, N1, N4, N6 for previous six months)
- •2. Serum or CSF neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1 and other)
- •3. Aged 18-70 years
- •4. Psychosis symptomatic as defined by PANSS =4 on P1, G9, P3, P2, G5, N1, N4, N6.
- •5. Patient or legal representative is willing and able to provide informed consent
排除标准
- •1. Duration of current episode of psychosis greater than 24 months
- •2. Alternative co-existing severe neurological disease, including tumour, hippocampal sclerosis with refractory epilepsy, probable dementia with evidence of atrophy on brain imaging, moderate or severe learning disability
- •3. Any evidence of a current acute encephalopathy (for instance coma, seizures)
- •4. Hepatitis B, Hepatitis C or HIV positivity; severe hypogammaglobulinaemia
- •5. Previous malignancy (to be usually excluded unless agreed with CI)
- •6. Pregnant, breast feeding or inadequate contraception if female
- •7. Hypersensitivity or absolute contra-indication to any study medication, murine proteins or excipients
- •8. Live vaccine within last three months
- •9. Previous treatment with rituximab in the past 12 months
- •10. Severe infection and severe heart failure
- •11. Any other medical illness or disability that, in the opinion of the investigator, would compromise effective study participation
- •12. Concurrent enrolment in other CTIMPs
研究者
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