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

1/2-合作研究：女性睾酮抗抑郁药增强

基本信息

批准号：
8582815
负责人：
MAURIZIO FAVA
金额：
$ 26.1万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-07-15 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8582815
关键词：
Academic Medical Centers Address Adverse effects Affect Androgens Antidepressive Agents Area Arousal Collaborations Data Data Analyses Depressed mood Disease remission Dose Endocrinology Fatigue Female Future Glycols Hormones Hospitals Intervention Intervention Studies Joints Libido Major Depressive Disorder Mental Depression Patients Pharmaceutical Preparations Physiological Physiological Processes Placebos Population Postmenopause Psychiatrist Psychiatry Public Health Quality of life Randomized Controlled Trials Recording of previous events Recruitment Activity Research Research Personnel Residual state Resistance Sample Size Sampling Selective Serotonin Reuptake Inhibitor Serotonin Uptake Inhibitors Severities Sex Functioning Sexual Dysfunction Site Study Subject Symptoms Testing Testosterone Therapeutic Validation Woman base career data management depressive symptoms double-blind placebo controlled trial drug candidate effective therapy efficacy testing experience hormone therapy improved interest multidisciplinary novel open label patient oriented research public health relevance randomized placebo controlled trial response suicidal risk

项目摘要

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.

描述（由申请人提供）：重度抑郁症是一个重大的公共卫生问题，对女性的影响尤为严重。尽管剂量充足，但约 70% 的患者对标准 SSRI 治疗没有反应或仅部分反应。在我们的开放标签试点数据中，三分之二的患有重度抑郁症且对抗抑郁药耐药或部分耐药的女性对极低剂量的生理性透皮睾酮给药产生了反应；接受治疗的女性中有三分之一在治疗 8 周后病情得到缓解，并且没有出现雄激素过多的副作用。我们提出了一项协作、随机、安慰剂对照试验，以确定是否需要进行更大规模的多中心试验调查低剂量睾酮对于患有重度抑郁症和 SSRI 部分/无反应的女性是否是一种有效且耐受性良好的增强策略。我们提议由两个学术医学中心进行一项协作、多学科研究，以增加样本量、加速招募并增加样本多样性。