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临床试验/NCT04797364
NCT04797364进行中(未招募)不适用

Pharmacogenetic Supported Prescribing in Kids

University of Calgary2 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2021年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
6,000
试验地点
2
主要终点
Adverse drug reactions

研究概览

简要总结

Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.

详细描述

Children with moderate to severe mental health conditions (e.g. depression, anxiety, OCD) or neurodevelopmental disorders (e.g., autism spectrum disorders, ADHD) are frequently prescribed medications as either the sole form of treatment or in combination with psychotherapy. However, up to 50% of these children will not respond or experience burdensome adverse drug reactions to these medications. Current use of mental health-related medications (e.g., antidepressants, antipsychotics) in children can be best described as a trial-and-error process that can impact the well-being of those taking the medications and their families at a considerable economic cost. However, this trial-and-error process could, in part, be avoided through the application of pharmacogenetic testing, a specific type of genetic testing that has the potential to improve drug efficacy and reduce the morbidity, mortality and cost associated with adverse drug reactions. The aim of this project is to implement and evaluate an evidence-based pharmacogenetic testing service to improve drug treatment outcomes in children receiving mental health care.

Our objectives are to:

  1. Implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.
  2. Collect performance, outcome, and economic indicators related to the pharmacogenetics testing service.
  3. Establish a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.

研究设计

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

入排标准

年龄范围
6 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Medical records available
  • The initiation, change, dose adjustment, or augmentation of psychiatric medication(s) is indicated
  • Treating psychiatrist, family physician, or pediatrician licensed in Alberta, British Columbia, Saskatchewan, or Manitoba requests pharmacogenetic testing

排除标准

  • Medically unstable or lacking capacity to provided informed consent
  • Unwillingness of child to provide saliva sample for genetic analysis
  • History of liver or bone marrow (hematopoietic cell) transplant

研究组 & 干预措施

Pharmacogenetic Testing

Experimental

Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)

干预措施: Pharmacogenetic Testing (Diagnostic Test)

结局指标

主要结局

Adverse drug reactions

时间窗: 6-months

Relative change in adverse drug reaction frequency

Symptom severity

时间窗: 6-months

Relative change in symptom severity

次要结局

  • Healthcare utilization(6-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chad Bousman

Associate Professor

University of Calgary

研究点 (2)

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