Assessment of the Inter-patient Variability in Clinical Response and Correlated Genetic Variations in Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pharmacogenomic analysis of SUD and medications used for the treatment of SUD.
研究概览
简要总结
This research outcomes can be summarized as follows:
- Pharmacogenomic analysis of Substance Use Disorder (SUD) and medications used for the treatment of SUD.
- Identification of novel genetic variations related to SUD specifically in the Egyptian population.
- Validation of currently known genetic variations associated with SUD. When the functional interpretation of common or rare variants in studied genes becomes available, such pharmacogenomic information can be used to improve pharmacotherapy individualization.
详细描述
This is a correlational cross-sectional study to investigate the correlation of some genetic variants to the predisposition to SUD in addicted patients as well as to the clinical response of the medications they receive as a part of their treatment plan.
Subjects participating in this study are those receiving outpatient or inpatient programs for the management of SUD with or without psychiatric disorders, supported by the specialized mental health care facility; "Al-Maa'moura Hospital for Psychiatry" in Alexandria.
An informed consent is obtained from each participant prior their contribution to the study. Approval from the General Secretariat of Mental Health and Addiction Treatment (GSMHAT), Ministry of Health and Population (MoHP), has been obtained before conducting the study as well as from the Ethics Committee, Faculty of Medicine, Alexandria University.
A minimal total sample size of 100 participants with SUD, male or female, and another 40 controls will be included in the study. This sample size was calculated with the assistance of instructors in the Department of Medical Statistics, Medical Research Institute, Alexandria University. The targeted sample is selected regarding the inclusion and exclusion criteria.
Patients' medical records will be checked to select the medications of interest. The medications selected include those most prescribed by the psychiatrists assigned at the hospital. They include quetiapine, carbamazepine, amitriptyline, olanzapine, sertraline, chlorpromazine, risperidone, and mirtazapine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Addicted patients receiving outpatient or inpatient treatment for SUD with or without psychiatric disorders at a mental health care facility.
排除标准
- •Patients with renal or hepatic impairment.
- •Patients receiving chemotherapy or radiotherapy.
研究组 & 干预措施
Addicted patients on treatment with psychiatric medications.
Addicted patients receiving treatment with either quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine or risperidone as oral dosage forms of usual prescribed doses for psychiatric disorders.
干预措施: Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone (Drug)
结局指标
主要结局
Pharmacogenomic analysis of SUD and medications used for the treatment of SUD.
时间窗: 1 year
次要结局
- Identification of novel genetic variations related to SUD specifically in the Egyptian population.(1 year)