跳至主要内容
临床试验/EUCTR2021-003588-85-BE
EUCTR2021-003588-85-BE进行中(未招募)1 期

Individualized care with antipsychotics in patients suffering from schizophrenia spectrum disorders-How to conciliate plasma concentrations, clinical response and genetic factors ?

CLouvain0 个研究点目标入组 100 人开始时间: 2021年10月12日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion criteria are : (1) diagnosis of schizophrenia-spectrum disorders7 (DSM-V 295.xx,
  • 298.9 and 297.1 ; or ICD-10 F20.xx, F25.xx, F29 and F22; or ICD-11 6A20, 6A21, 6A2Z and
  • 6A24), (2) hospitalized in a psychiatric unit of each center for an acute episode of psychosis, (3) aged between 18 and 65 years old at admission; and (4) taking a monotherapy8 of
  • aripiprazole, olanzapine or risperidone at admission or any time during their hospital stay for
  • their psychotic symptoms until steady state of their antipsychotic is reached.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion criteria are: (1) comorbid disorder of intellectual development (i.e. intellectual
  • disability also commonly called mental retardation, DSM-V criteria 317.xx and 318.xx), (2)
  • comorbid serious uncontrolled illness or dementia9; (3) comorbid substance use disorder (DSMV
  • 305.20, 304.30, 305.90, 304.60, 305.30, 304.50, 305.50, 304.00, 305.40, 304.10, 305.70,
  • 305.60, 304.40, 304.20) in case of consumption during the hospital stay10 (4) comorbid alcohol
  • use disorder (DSM-V 305.00 and 303.90); (5) women with a current pregnancy11 ; (6)
  • hospitalization for a social purpose (e.g. nursing home time out) or planned hospitalization
  • without exacerbation ; (7) patients not speaking French, English or Dutch to a standard
  • necessary to receive the assessment scales; (8) patients with an hepatic fibrosis Child Pugh C
  • and severe renal failure (i.e. Clcr <30 mL/min) identified through chart review.

研究者

发起方
CLouvain

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