DHEA EFFECTS ON MOOD IN DEPRESSED HIV+ PATIENTS

这是一项双盲安慰剂对照的抗抑郁药临床试验 DHEA在HIV+个体中的作用。次要目标包括 确定DHEA是否具有合成代谢作用或雄激素作用 对入组受试者的影响。调查人员将考虑基本的 肾上腺类固醇代谢的内分泌学，并建议 评估DHEA对免疫状态和病毒活性的影响， 在HIV感染者中使用DHEA的安全性。 这项研究是一项为期八周的双盲对照试验，口服DHEA与口服DHEA相比。 安慰剂，药物应答者为8周维持期， 向安慰剂无应答者提供的开放治疗（8周后 双盲试验）。他们提出了1：1的随机化，并预测114 参加的个人将完成为期八周的试验。如果DHEA改善 抑郁症状，以及增加性欲和减少肌肉损失 质量，那么调查人员将确定一个广泛的干预， 适合感染艾滋病毒的男女的一系列行动，即 实用、便宜、方便。 关于内分泌研究，研究人员将评估 以及口服该化合物前后DHEA的代谢物， 并检测皮质醇、甘油三酯、胰岛素、胆固醇、生长 激素、IGF-1和IGF-1结合蛋白。将在研究时进行检查 基线、第4周和第8周，包括标准剂量ACTH、低剂量ACTH、CRF和 GnRH刺激试验，以评估下丘脑-垂体-肾上腺和 DHEA给药前后下丘脑-垂体性腺功能。 这将使研究人员能够评估潜在的潜在机制 DHEA对情绪、性欲和身体的治疗效果 混合物.

This is a double blind, placebo-controlled clinical trial of the antidepressant effect of DHEA among HIV+ individuals. Secondary goals will include determination of whether DHEA has anabolic effects or androgenic effects on enrolled subjects. The investigators will consider the basic endocrinology of adrenal steroid metabolism in the subjects, and propose to assess the effects of DHEA on immune status and viral activity with regard to the safety of the use of DHEA in HIV infected individuals. The study is an eight week double blind controlled trial of oral DHEA vs. placebo with an eight week maintenance phase for drug responders, and 16 weeks of open treatment offered to placebo non-responders (after the eight week double blind trial). They propose a 1:1 randomization and predict that 114 enrolled individuals will complete the eight week trial. If DHEA ameliorates depressive symptoms, as well as increasing libido and reducing loss of muscle mass, then the investigators will have identified an intervention with a broad spectrum of action suitable for both men and women with HIV infection, that is practical, inexpensive, and accessible. With regard to the endocrine studies, the investigators will assess precursors and metabolites of DHEA before and after oral administration of the compound, and examine effects of cortisol, triglycerides, insulin, cholesterol, growth hormone, IGF-1, and IGF-1 binding proteins. Tests will be administered at study baseline, weeks 4 and 8, including standard dose ACTH, low dose ACTH, CRF, and GNRH stimulation tests to assess the hypothalamic-pituitary-adrenal and hypothalamic-pituitary gonadal function before and after DHEA administration. This will permit the investigators to assess potential underlying mechanisms for the putative therapeutic effects of DHEA on mood, libido, and body composition.