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
- 1
- 主要终点
- Hamilton Depression Scale (HAM-d)
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
Hamilton Depression Scale (HAM-d)
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)
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 (1)
Loading locations...
相似试验
已完成
不适用
The Effect of Testosterone on Mood and Quality of LifeGonadal DisordersDepressive DisorderHypogonadismNCT00202462Seattle Institute for Biomedical and Clinical Research33
已完成
不适用
Testosterone and Major DepressionMajor DepressionNCT00286546University Health Network, Toronto100
已完成
1 期
To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD LotionHypogonadismNCT00857168Acrux DDS Pty Ltd36
已完成
4 期
TRT on BPH Hypoganadal MetS Patients. Florence-PROTESTLower Urinary Tract SymptomsHypogonadismProstatic HyperplasiaNCT02366975University of Florence143
终止
4 期
TOM: Testosterone in Older Men With SarcopeniaSarcopeniaHypogonadismMuscular DiseasesNCT00240981Boston Medical Center209