Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
研究概览
简要总结
This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).
详细描述
Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
- •Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
- •Taking or be newly prescribed an anti-depressant or anti-psychotic medication
- •Able to provide informed consent
排除标准
- •Pregnant or breastfeeding
- •Active and/or unstable diagnosis of substance abuse, excluding nicotine
- •Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder
结局指标
主要结局
Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
时间窗: 24 weeks
response to medication following medication recommendation guided by pharmacogenetic testing
次要结局
- Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)(24 weeks)