A Phase III Double-Blind Randomized Trial Comparing Sertraline (Zoloft) And Hypericum Perforatum (St. John's Wort) In Cancer Patients With Mild To Moderate Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Depression severity as measured by Hamilton Depression rating scale.
研究概览
简要总结
RATIONALE: Antidepressants such as sertraline and the herb hypericum perforatum (St. John's wort) may be effective in treating mild to moderate depression. It is not yet known which treatment is more effective in improving depression in patients who have cancer.
PURPOSE: This randomized phase III trial is studying how well sertraline works compared to St. John's wort in treating mild to moderate depression in patients with solid tumors.
详细描述
OBJECTIVES:
- Compare the change in depression severity in cancer patients with mild to moderate depression treated with sertraline vs Hypericum perforatum.
- Compare the severity of somnolence, nausea, and insomnia in patients treated with these regimens.
- Compare the impact of these regimens on fatigue in these patients.
- Correlate hyperforin concentrations with change in depression severity in patients treated with Hypericum perforatum.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to level of depression (mild vs moderate), concurrent radiotherapy (yes vs no), and TNM stage (I, II, or III vs IV). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sertraline daily.
- Arm II: Patients receive oral Hypericum perforatum daily. In both arms, treatment continues for 4 months in the absence of unacceptable toxicity.
Measurements of depression, somnolence, nausea, insomnia, fatigue, and hyperforin concentration are assessed at baseline, and at 1, 2, and 4 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Sertraline (Zoloft) 50 mg
Zoloft 50 mg by mouth daily for 1 week if tolerated dose may be increased to 100 mg daily for 4 months
干预措施: Zoloft 50 mg (Drug)
Arm 2 - St. John's Wort 600mg
St. John's wort 600 mg daily for 1 week. If tolerated dose may be increased to 900 mg daily for four months.
干预措施: St. John's Wort 600 mg (Dietary Supplement)
结局指标
主要结局
Depression severity as measured by Hamilton Depression rating scale.
时间窗: 4 months
To compare the change in depression severity in cancer patients with mild to moderate depression on sertraline and St. John's wort.
次要结局
- Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale.(4 months)
- Somnolence, nausea, and insomnia as assessed by the NCI Common Toxicity Criteria. The Epworth Sleepiness Scale will also be used to assess somnolence.(4 months)