Collaborative Study: Testosterone Antidepressant Augmentation in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Depressive Symptom Severity
研究概览
简要总结
The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive symptoms in women with Major Depressive Disorder (MDD) and antidepressant partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation improves fatigue and sexual dysfunction.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age 21-75
- •Major depressive disorder including MADRS>/=12
- •Currently treated with an antidepressant monotherapy (1st, 2nd or 3rd trial in current episode), that has been taken at an adequate dose for at least six weeks.
排除标准
- •Serious suicide or homicide risk, as assessed by evaluating clinician
- •Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
- •Substance use disorder active within last six months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at time of screening based on history and/or laboratory results.
- •Any history of psychotic features, bipolar disorder, or primary obsessive compulsive disorder, as assessed by SCID
- •Currently treated with typical or atypical antipsychotic medications, or lithium
- •Untreated hypothyroidism. If treated hypothyroidism, change in levothyroxine dose within the prior 3 mos
- •Use of androgens, including testosterone, dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
- •Any investigational psychotropic drug within the last thirty days
- •In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period (three or more episodes of self-harm in the past year, documented history of poor treatment adherence, or frequent missed appointments (>50%) in the past year)
- •ALT > 3x upper limit of normal or creatinine> 3x upper limit
- •History of a hormone-responsive cancer
研究组 & 干预措施
Testosterone
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
干预措施: Testosterone (Drug)
Placebo
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Depressive Symptom Severity
时间窗: Week 8
Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.
次要结局
- Fatigue(Week 8)
- Sexual Dysfunction(Week 8)
研究者
Karen Klahr Miller, MD
Associate Professor of Medicine, Harvard Medical School
Massachusetts General Hospital