A Three-armed Randomised Controled Trial on the Effect of Genotyping for CYP450 Polymorphisms and Intense Clinical Monitoring on Antipsychotic Drug Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Time to discontinuation of initial antipsychotic treatment
研究概览
简要总结
The purpose of this study is to determine whether genotyping for CYP2D6 and 2C19 polymorphisms or intense clinical monitoring of treatment and adverse effects improves the antipsychotic treatment in patients with schizophrenia. This study is designed as a three-armed prospective randomized controlled clinical trial and includes 300 patients with schizophrenia. Patients are followed for a period of one year.
During the study period the following effect measures are registered:
- Time to discontinuation of all antipsychotic medications
- Number of changes in medication dose
- Number of changes in medication
- Compliance (patients´ adherence to medical treatment)
- Clinical symptoms
- Adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Diagnosed with schizophrenia
- •Able to give written informed consent
排除标准
- •Genotyped prior to inclusion
研究组 & 干预措施
Genotyping for CYP4502D6 and 2C19 polymorphisms
In this study arm (1) the genotype information is given to the physician in charge of treatment and can be used to direct the pharmacological treatment in accordance with the current guidelines from Sct. Hans hospital. In the guidelines the genotype is translated to the clinical designation "normal", "slow" or "fast" metabolizer of CYP2D6 or "normal" or "slow" metabolizer of CYP2C19. Different treatment options for the different genotypes are described in the clinical guidelines.
干预措施: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms (Genetic)
(2) Intense clinical monitoring
In this study arm (2) the genotype information is not revealed. The intervention consists of an intensified clinical monitoring of treatment effect, side effects and patient perspective. Staffpersonnel is trained in the use of a clinical manual that builds on a selection of validated questions from the Scale for the Assessment of Positive Symptoms (SAPS), Side effect score (Udvalg af Kliniske Undersøgelser (UKU) and Rating of Medical Influences (ROMI). The manual has to be used at least once in a quarter (every third month), which is monitored by the study personnel. Data registered by the patients primary contact person are not used as outcome measures in the study but only as intervention tool for the optimisation of the medical antipsychotic treatment.
干预措施: (2) Intense clinical monitoring (Other)
(3) Control
In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
干预措施: (3) Control (Other)
结局指标
主要结局
Time to discontinuation of initial antipsychotic treatment
时间窗: one year
次要结局
- Compliance(one year)
研究者
Gesche Jurgens
MD, PhD
Bispebjerg Hospital