Duloxetine for the Treatment of Dysthymia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Inventory of Depressive Symptomatology (Clinician-Rated)
研究概览
简要总结
The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of 60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low more days than not for more than 2 years.
详细描述
The purpose of this research is to obtain information on the safety and effectiveness of duloxetine (Cymbalta) in the treatment of dysthymia. Duloxetine has been approved by the federal Food and Drug Administration for the treatment of depression. The use of duloxetine for treatment of dysthymia is considered experimental.
Dysthymia is defined as chronic, low-grade depression, characterized by feeling low or depressed, that lasts for two or more years. Additional symptoms may include: poor appetite or overeating; insomnia or sleeping too much; low energy or fatigue; low self-esteem; poor concentration or difficulty making decisions; and feelings of hopelessness.
Dysthymia affects 3-6% of the general population, but is an underdiagnosed and undertreated disorder. In double-blind, placebo-controlled clinical trials of antidepressant medications, dysthymia response rates are around 60%, compared to an average placebo response rate of about 30%. Duloxetine has not been studied in the treatment of dysthymia, but has shown results in the treatment of major depression. In a 9-week, double-blind, placebo-controlled study of 257 patients with major depression, 65% responded to duloxetine 60mg/day, compared to 43% to placebo. Based on these results, it is highly likely that duloxetine will be an effective treatment for dysthymia.
This research study is being conducted at Stanford University Medical Center with a total of 24 patients, age 18 and above, with dysthymia.
In the study, subjects will receive duloxetine for 12 weeks. This is an open-label study, which means that every subject receives the study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Sign an informed consent form
- •18 years of age or older
- •Females not pregnant or breastfeeding or planning pregnancy and using an acceptable form of contraception
- •Meet DSM-IV criteria for dysthymia
- •A screening IDS-C score of 17 or greater
- •No history of serious or unstable medical disorder
- •Not taking any significant concurrent medications
- •Not currently receiving psychotherapy
排除标准
- •Suffering from DSM-IV defined
- •delirium, dementia, amnestic, or other cognitive disorders
- •mental disorders due to a general medical condition
- •factitious or somatoform disorders
- •mental retardation or developmental disabilities
- •substance or alcohol abuse within the last 3 months
- •depressive disorders with current suicidal risk
- •psychotic disorders including delusional disorder, somatic type
- •dissociative disorder
- •personality disorders sufficiently severe to interfere with study participation
- •History of DSM-IV defined bipolar I or II disorder
- •History of non-response of dysthymia to adequate antidepressant medication
- •History of major depression refractory to two adequate trials of antidepressants
结局指标
主要结局
Inventory of Depressive Symptomatology (Clinician-Rated)
次要结局
- Clinical Global Impressions - Improvement
- Zung Self-Rating Depression Scale
- Patient Global Improvement
- Brief Pain Inventory
- WHO-QOL 100