2022-502902-33-00招募中4 期
Safety and efficacy of olanzapine treatment in psychosis: Effect of genetic and epigenetic factors – covariates of treatment response
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Frequency of gene polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4
研究概览
简要总结
The primary aim is to evaluate proportions (frequency) of gene polymorphisms in CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4 genes in the study population of patients with schizophrenia.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18‒60 years
- •Dg. F20 (schizophrenia) or F25 (schizoaffective disorders) according to ICD-10
- •Established treatment with olanzapine, or planned initiation of olanzapine treatment
- •Expressed the informed consent and will to co-operate
- •Women of childbearing potential can be included only if they are using at least an acceptable effective contraceptive measure (Chapter 8.10)
排除标准
- •Sui juris restriction or divestiture
- •Olanzapine or caffeine contraindication
- •Pregnancy, or planning to conceive, breastfeeding
- •Prior participation in any other trial involving investigational medication or medical devices within 14 days prior to the enrolment and during this trial
- •Other serious medical or psychiatric illness that is not adequately controlled and, in the investigator’s opinion, would not permit the subject to be managed according to the protocol
结局指标
主要结局
Frequency of gene polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4
Frequency of gene polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4
次要结局
- Cytosine methylation of 5HT2A
- Metabolic phenotype of CYP1A2
- Response rate: The treatment response is defined as 20% reduction in PANSS score (see Chapter 7.2) on day 14 or 30% reduction in PANSS score on day 28 compared to baseline score.
- Remission rate: Remission is defined in compliance with the “Remission in Schizophrenia Working Group” as reduction of the severity of symptoms evaluated in items P1, P2, P3, G5, G9, N1, N4, N6 of PANSS scale to ≤ 3 degree; with respect to the study period, although the original recommended time factor (6 months) will not be included in the evaluation.
- Time to reach the treatment response (i.e., 20% reduction in PANSS score).
- Number of "drop-outs" (olanzapine treatment cessation) and their reasons.
- Side effects assessment: UKU scale (see Chapter 8.3)
- Treatment of the adverse effects of olanzapine – medication, doses, treatment duration, changes in olanzapine administration.
研究者
Jan Juřica
Scientific
Masarykova Univerzita
研究点 (2)
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