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临床试验/NCT01454453
NCT01454453终止4 期

Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET

Institute of Psychiatry, London1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
64
试验地点
1
主要终点
dose titration

研究概览

简要总结

Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and distressing symptoms in older people. Although these drugs can be beneficial, they are associated with side effects, particularly in patients with dementia and schizophrenia- like illness. There is an urgent clinical need to understand why this is the case, to guide treatment strategies.

This study aims to utilise brain imaging techniques that measure the action of antipsychotic drugs in the brain to explore the causes of this susceptibility in older people with dementia and schizophrenia-like illness, and translate these findings into direct patient benefit.

The aim of the study is to investigate and compare the relationship between the action of amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient groups - Alzheimer's disease and schizophrenia-like illness. Imaging data will be combined with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom reduction and motor side effects) during dose titration.Dose-response modelling will be carried out in both groups to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patients - dose titration

Experimental

Amisulpride 50-200mg, 4-12 weeks, with brain imaging

干预措施: Patients- dose titration (Drug)

结局指标

主要结局

dose titration

时间窗: 12 weeks

receptor occupancy compared across 2 patient groups following dose-titration

次要结局

未报告次要终点

研究者

发起方
Institute of Psychiatry, London
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne Reeves

Clinician Scientist

Institute of Psychiatry, London

研究点 (1)

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