Duloxetine for Chronic Depression: a Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS) - 24 Total Score
研究概览
简要总结
The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).
Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.
Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.
详细描述
This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or Depression, Not Otherwise Specified (Depression NOS).
The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.
Tests of cytokine functioning will be performed and analyzed for treatment and placebo effects.
In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 to 75 years (ages 20 to 60 for MRI sub-study)
- •diagnosis of dysthymic disorder (chronic depression) or depression NOS
- •minimum of 2 years duration of current episode of depression
排除标准
- •current major depression
- •diagnoses including delirium, dementia, bipolar disorder, schizophrenia
- •substance abuse or dependence in the past 6 months
- •pregnant or nursing women
- •serious risk of suicide
研究组 & 干预措施
duloxetine (cymbalta)
Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine
干预措施: Duloxetine (Cymbalta) (Drug)
Placebo treatment
placebo treatment: treatment with placebo capsules that match active medication capsules
干预措施: Duloxetine (Cymbalta) (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS) - 24 Total Score
时间窗: Baseline
HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
次要结局
- Cornell Dysthymia Rating Scale (CDRS)(Baseline)
- Global Assessment of Functioning Scale (GAF)(Baseline)
- Beck Depression Inventory (BDI)(Baseline)
- Clinical Global Impressions Improvement(CGI-I)(10 weeks)