Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Score on the Hamilton Rating Scale for Depression (HAMD-17)
研究概览
简要总结
This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate clinical impact of pharmacogenomic testing on the treatment of major depressive disorder. Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group (guided group) and treatment as usual group (TAU group). The primary hypothesis is the pharmacogenomic-guided treatment group will demonstrate significantly higher percent improvement in depression score compared to treatment-as-usual group.
详细描述
To a large extent, variability in antidepressant efficacy can be explained by genetic variations that affect medication-metabolizing enzymes, drug transporters, and medication targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in improving treatment of major depressive disorder. One of the major barriers towards successful implementation of pharmacogenomic testing for patients with major depressive disorder is lack of systematic evaluation of impact of this approach in routine clinical care settings. The major goal of this study is to systematically evaluate impact of comprehensive pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of major depressive disorder (MDD)
- •Prescription of index antidepressant medications
- •Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)
排除标准
- •Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
- •Active diagnosis of substance abuse or dependence
- •Current suicidal ideation
- •Previous suicidal attempts
- •A person has already had pharmacogenetic testing done.
结局指标
主要结局
Score on the Hamilton Rating Scale for Depression (HAMD-17)
时间窗: Up to 10 weeks
The patient is rated by a clinician among 17 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.
次要结局
- Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR)(Up to 10 weeks)
- Score on the 9-item Patient Health Questionnaire (PHQ-9)(Up to 10 weeks)