A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 21-item Hamilton Depression Rating Scale Score (HAM-D)
研究概览
简要总结
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant.
During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.
详细描述
We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •30-65 years old
- •Taking at least one serotonergic antidepressant at adequate dose for at least six weeks but still meeting DSM-IV criteria for major depressive disorder within the past year
- •HAM-D score >12
排除标准
- •Current suicidal ideation
- •Substance abuse or dependence within the past year
- •Current or past psychotic symptoms
- •A history of bipolar disorder
- •A prostate-specific antigen (PSA) level greater than 4.0 ng/ml
- •Other clinically significant medical condition
- •A history of failing to show any clinically significant response to two or more adequate trials of different antidepressants.
研究组 & 干预措施
testosterone gel
AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily
干预措施: Testosterone gel (Drug)
placebo gel
Placebo gel
干预措施: Placebo (Drug)
结局指标
主要结局
21-item Hamilton Depression Rating Scale Score (HAM-D)
时间窗: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)
The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
次要结局
- Montgomery Asberg Depression Rating Scale (MADRS)(9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment))