Cost-effectiveness of CYP2D6 and CYP2C19 Genotyping in Psychiatric Patients in Curacao
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- BPRS
研究概览
简要总结
The cytochrome P450 (CYP) is a group of metabolic enzymes, from which the 2D6 and CYP2C19 polymorphisms are specifically related to the metabolism of psychiatric drugs. The prevalence of CYP2D6 and CYP2C19 polymorphisms differs among ethnicities. Depending on the number of functional alleles, individuals are classified as Poor Metabolizer (PM), Intermediate Metabolizer (IM), Extensive Metabolizer (EM) or Ultra Rapid Metabolizer (UM).
Research has suggested that PM genotype is a predisposing factor for antipsychotic-induced side-effects. Besides susceptibility for side effects and lower quality of life, also, a relationship between phenotype and costs of care has been shown.
Guidelines recommend that PM, IM and UM genotypes need dose adjustment, to optimize the effectiveness of the drug and/or to reduce side effects. No research has been done to investigate cost-effectiveness of implementation of genotyping in daily clinical psychiatric practice.
This study investigates the effectiveness of implementation of CYP2D6 and CYP2C19 genotyping in psychiatric patients in Curacao and analyzes the costs of genotyping versus health benefits.
详细描述
Subjects
This study is carried out on the Caribbean island Curacao and in the Netherlands. The population (approx. 150,000 inhabitants) of Curacao is mainly of Negroid descent. Participants were recruited from the Klinika Capriles, (the only psychiatric hospital on the island) the psychiatric ward in the prison (FOBA) and the psychiatric polyclinic on the island (Psychiaters Maatschap Antillen). The study protocol was approved by the Medical Ethical Review Board (Maastricht) and study participants gave written informed consent after explanation about the study.
Inclusion criteria were: (i) An Antillean ethnicity, defined in line with the Dutch Central Bureau of Statistics as birth on the former Dutch Antilles and birth of at least one parent on the former Dutch Antilles. (ii) Age 18 years or older. (iii) The use of an antipsychotic or antidepressant and (iv) informed consent.
All the patients were genotyped and grouped according to predicted phenotype for CYP2D6 and CYP2C19. Information about medication use was collected. Patients using CYP2D6 or CYP2C19 inhibiting medication according to Flockhart were selected. Enzyme activity scores of patients using a strong inhibitor were multiplied by 0 which meant they converted automatically to a PM phenotype. In patients using medium inhibitors, activity scores were multiplied by 0.5. This is a widely used and accepted method.
All prescribed antipsychotics were calculated to a "Defined Daily Dose" (DDD) as defined by the World Health Organization (WHO). For every patient the total equivalent of the DDD was calculated. In this way it was possible to analyse if there were differences in total dose of antipsychotics being used between the phenotype groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Antillean ethnicity, defined in line with the Dutch Central Bureau of Statistics as birth on the former Dutch Antilles and birth of at least one parent on the former Dutch Antilles
- •age 18 years or older
- •use of an antipsychotic or antidepressant drug
- •written informed consent.
排除标准
- •no informed consent
结局指标
主要结局
BPRS
时间窗: 4 months
Improvement on psychiatric symptoms
St Hans Rating Scale
时间窗: 4 months
Improvement on movement disorders
WHODAS 2.0
时间窗: 4 months
Improvement on global functioning
次要结局
- BMI(4 months)
- EQ 5D(4 months)
- blood pressure(4 months)
- cholesterol spectrum(4 months)
- SWN-20(4 months)