NCT00260390Unknown4 期
The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 试验地点
- 2
- 主要终点
- Clinical Global Impression- Change (CGI-C)
研究概览
简要总结
Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
Hypothesis:
Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age 40-80 years.
- •Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
- •Diagnosis of Dysthymic disorder with onset after age
- •Normal digital exam of the prostate in the preceding 1 year.
- •For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
- •Able to give informed consent.
排除标准
- •Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
- •Currently being treated with testosterone.
- •Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
- •Current suicidal risk.
- •Current (past year) substance abuse or dependence.
结局指标
主要结局
Clinical Global Impression- Change (CGI-C)
Profile of Mood States (POMS)
Beck Depression Inventory (BDI)
Sheehan Disability Scale
Self Anchoring Scale (SAS)
Affective Balance Scale (ABS)
Hamilton Depression Scale (HAM-d)
International Index of Erectile Function (IIEF)
Aging Male Symptom rating (AMS)
Clinical Global Impression (CGI)
次要结局
未报告次要终点
研究者
研究点 (2)
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