1/2-Collaborative Study: Testosterone Antidepressant Augmentation in Women

描述(由申请人提供)：严重抑郁障碍是一个严重的公共卫生问题，对女性的影响不成比例。大约70%的患者对标准的SSRI治疗没有反应或只有部分反应，尽管剂量足够。在我们的开放标签试验数据中，三分之二对抗抑郁药物耐药或部分耐药的患有严重抑郁障碍的女性对极低剂量的生理性经皮睾酮治疗有反应；三分之一的接受治疗的女性在治疗8周后获得缓解，没有高雄激素副作用。我们建议进行一项协作性、随机性、安慰剂对照试验，以确定是否需要更大规模的多中心试验。 目的：研究小剂量睾酮对患有严重抑郁障碍和SSRI部分/无反应的女性是否有效和耐受性良好的强化治疗策略。我们建议从两个学术医学中心进行一项合作的、多学科的研究，以增加样本量，加速招募，并增加样本多样性。

DESCRIPTION (provided by applicant): Major depressive disorder is a significant public health problem, disproportionately affecting women. Approximately 70% of patients do not respond or only partially respond to standard SSRI treatment despite adequate dosing. In our open-label pilot data, two-thirds of women with major depressive disorder who were resistant or partially resistant to antidepressants achieved a response to very low-dose, physiologic transdermal testosterone administration; one-third of women treated achieved remission after 8 weeks of therapy, with no hyperandrogenic side effects. We propose a collaborative, randomized, placebo-controlled trial to determine whether larger, multi-center trials are indicated to investigate whether low-dose testosterone is an efficacious and well-tolerated augmentation strategy in women with major depressive disorder and SSRI partial/nonresponse. We propose a collaborative, multidisciplinary study from two academic medical centers in order to increase sample size, accelerate recruitment and increase sample diversity.