Patient Outcomes With Education, Drug Therapy, and Support (POETS): A Multicenter, Open-label, Randomized Study to Evaluate Depressed Subjects Treated With Venlafaxine Extended-release vs. Venlafaxine Extended-release Plus the Dialogues Time to Talk Program in a Primary Care Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 537
- 试验地点
- 44
- 主要终点
- Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)
研究概览
简要总结
The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, providing feedback to treating physicians, and encouraging better physician-patient communications.
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
- None
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
- •Currently experiencing a major depressive episode, which requires the initiation of antidepressant drug treatment or a change in current antidepressant drug treatment
- •At least 18 years of age
排除标准
- •History or presence of bipolar disorder
- •Current treatment with venlafaxine
结局指标
主要结局
Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)
时间窗: 112 days
Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). "Very satisfied" was defined as a score of greater than or equal to 8.
次要结局
- Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks(Baseline and 112 days)
- Patient Global Impression of Improvement (PGI-I) Score(112 days)
- Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks(Baseline and 112 days)
- Number of Patients Compliant With Therapy(112 days)
- Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks(Baseline and 112 days)
- Change in Sheehan Disability Scale Score From Baseline to 16 Weeks(Baseline and 112 days)
- Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks(112 days)