Antidepressant Medication Adherence in Adults With Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 525
- 试验地点
- 2
- 主要终点
- Depression symptom response 12 weeks
研究概览
简要总结
The goal of this study is to test ways to help people improve their health and manage their medication for depression. This study will measure both medication adherence and depression outcomes.
详细描述
Participants in the study will be given a special pill bottle for depression medication. This pill bottle will track how often the bottle is opened to take medication and it will transmit that information to the research team. Participation will last 12 weeks, and will include an initial assessments over the phone and follow-up assessments over the phone or electronically approximately 6 weeks and 12 weeks later. During these assessments, a research coordinator will ask questions about your mood, quality of life, participation in the management of depression, and related topics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Penn Medicine primary care outpatients
- •Clinical diagnosis of major depressive disorder
- •A score of 10+ on the Patient Health Questionnaire 9 (PHQ-9)
- •Age 21 to 64 years at the time of study entry
- •Prescribed an antidepressant by their primary care clinician
- •Express interest in taking antidepressant medication
- •Own a cell phone
- •Capable of using the electronic pill bottle
- •English-speaking
排除标准
- •Treated with antidepressants in the past 90 days
- •Pregnant or breastfeeding
- •An active substance use disorder other than nicotine
- •A lifetime history of treatment for bipolar disorder or schizophrenia
- •Hospital admission or emergency department visit for suicidal symptoms in the past year
- •Lack capacity to provide informed consent
- •Using antidepressant more than 10 days at baseline assessment
结局指标
主要结局
Depression symptom response 12 weeks
时间窗: 12 weeks from baseline
A reduction of 50% in depression score from baseline as assessed by PHQ-9
次要结局
- Antidepressant adherence(6 and 12 weeks)
- Depression symptom response 6 weeks(6 weeks from baseline)