NCT01141387已完成不适用
Clinical Outcomes in MEasurement-Based Treatment (COMET)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 914
- 主要终点
- Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
研究概览
简要总结
The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive monthly reports.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years old
- •Diagnosis of major depressive disorder
- •Prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'New' is defined as no antidepressant use in the previous 120 days
- •Primary depression management is performed by the primary care provider
- •Capable of self-management (i.e., taking medications and independently responding to follow-up contacts)
- •Able to provide informed consent to participate
- •Sufficient ability as judged by the physician to read, understand and complete survey instruments written in English and phone interviews spoken in English
排除标准
- •History psychotic disorder or bipolar disorder
- •Diagnosis of current postpartum depression
- •Diagnosis of bereavement less than 8 weeks duration
- •Currently pregnant
- •History of suicide attempts or current suicide plan
- •Need for psychiatric hospitalization at enrollment visit
- •History of adjunctive treatments including electroconvulsive treatment (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), or deep brain stimulation (DBS)
结局指标
主要结局
Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
时间窗: Follow-up upto 6 months
次要结局
- Response rate assessed by the PHQ-9 instrument(6 months)
- The medication prescribed including refills, dose titrations, switching and augmentation(6 months)
- Health care utilizations including office visits, emergency room visits and hospitalization(6 months)
研究者
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