The myGenes Study:Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Response, as defined by > 50% reduction in Hamilton Depressing Rating Scale ( HAM-D)
研究概览
简要总结
The purpose of this study is to understand the effectiveness of pharmacogenomic testing in using antidepressants and to understand how EHR - driven clinical decision support system can be used to deliver PGx test results by healhcare providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who quality the criteria below:
- •Patients with nonpsychotic MDD
- •Patients who would like to either start a new antidepressant or change their existing antidepressant treatment
- •Patients for whom antidepressant treatment is deemed appropriate by the treating clinician
- •>18 years of age
- •Willingness to provide signed informed consent to participate in the study
- •Will be following up or continuously visiting their physician
- •Outpatient practice providers
- •Providers who are familiar with Epic
排除标准
- •Patients with medical contraindications that preclude antidepressant treatment
- •Patients with schizophrenia, schizoaffective disorder, or who have Bipolar I disorder
- •Patients currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants)
- •Patients who are pregnant or have severe cognitive impairment
- •Patients requiring urgent care or inpatient hospitalization at the time of consent
- •Unable or unwilling to commit time to introduce myGenes study to patients
研究组 & 干预措施
Intervention group
Intervention group will have the PGx test results available via Epic, three days after the biospecimen is received.
干预措施: Genomind®Professional PGx Express TM (Genetic)
Control group
The control group will be considered in TAU(treatment as usual) group but will have the PGx test results available after 24 weeks.
Note: Patient in both the groups will be followed for 24 weeks and will take questionnaires every other week.
干预措施: Genomind®Professional PGx Express TM (Genetic)
结局指标
主要结局
Response, as defined by > 50% reduction in Hamilton Depressing Rating Scale ( HAM-D)
时间窗: 24 weeks
The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. The scoring system is as follows- 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-23 = Severe Depression \> 23 = Very severe Depression.
Remission, as defined by < 8 on Hamilton Depressing Rating Scale ( HAM-D).
时间窗: 24 weeks
The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. The scoring system is as follows- 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-23 = Severe Depression \> 23 = Very severe Depression.
Conformance between antidepressant medication prescription changes and recommendations from the pharmacogenomics testing
时间窗: 24 weeks
Conformance is defined as the number of prescriptions that are in agreement with clinical decision support recommendations based on pharmacogenomics test results.
次要结局
- Self-reported side effects(24 weeks)
- Provider Attitude(24 weeks)