CDDOM Oneome Rightmed Depression Study
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 主要终点
- determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication
研究概览
简要总结
In this study, we hypothesize PGx guided testing can improve outcomes related to treatment of moderate and severe depression among El Rio Community Health patients. We anticipate patients randomized to the OneOme RightMed® PGx test will demonstrate a greater improvement of depressive symptoms and will have a higher proportion of subjects reporting response and remission than those receiving standard care.
Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population.
详细描述
In this study, we hypothesize PGx guided testing can improve outcomes related to treatment of moderate and severe depression among El Rio Community Health patients. We anticipate patients randomized to the OneOme RightMed® PGx test will demonstrate a greater improvement of depressive symptoms and will have a higher proportion of subjects reporting response and remission than those receiving standard care.
Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population.
Primary Outcomes:
- Changes in patient depressive ratings will be the primary endpoint in this study. The primary outcome will be measured using the validated Patient Health Questionnaire (PHQ-9) depression rating scale, administered verbally to participants.
Depression response and remission rates (proportion of subjects achieving or not achieving), in the control and intervention arm will be directly compared at baseline, 2, 4, 8, and 12 weeks. 2. Patient progression from primary care to El Rio behavioral health (BH) specialty care will also be monitored in this study. We will directly compare the proportion of subjects in the control and intervention arm requiring BH consultation at any point in the study.
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
- Double (Participant, Investigator)
盲法说明
Primary study Investigator(s) and analyzers of samples with be masked. Only one co-I responsible for group randomization will be unmasked to study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years of age
- •PHQ-9 score ≥ 10
- •Suffer from Major Depressive Disorder meeting DSM-V criteria and meet at least one of the following:
- •Either new to antidepressant treatment or currently taking medication for less than 6 weeks.
- •Inadequate efficacy after at least 6 weeks of antidepressant treatment
- •Have discontinued antidepressant treatment due to adverse events or intolerability within the last 6 weeks
- •Must be able to understand requirements of the study and provide written informed consent (English or Spanish)
排除标准
- •Any patient for whom providing a buccal swab sample would be contraindicated or not possible.
- •Patients taking antidepressants for > 6 months consecutively prior to baseline unless determined to be inadequate efficacy and PCP looking to change medication.
- •Subjects diagnosed as not having or depression.
- •Patients with history of prior PGx testing
- •Inability to provide informed consent
- •Current diagnosis of bipolar disorder type I or II, psychosis, schizophrenia and/or schizoaffective disorder
- •Inability to attend scheduled study visits
- •Patients who are known to be pregnant or lactating
- •Patients that are diagnosed with severe depression
结局指标
主要结局
determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication
时间窗: 2 years
Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population 1.) Changes in patient depressive ratings will be the primary endpoint in this study. The primary outcome will be measured using the validated Patient Health Questionnaire (PHQ-9) depression rating scale, administered verbally to participants.
次要结局
未报告次要终点
研究者
Lawrence Mandarino
Professor, Division Chief, CDDOM Director
University of Arizona