DHEA EFFECTS ON MOOD IN DEPRESSED HIV+ PATIENTS

DHEA 对抑郁 HIV 患者情绪的影响

• 批准号: 6148353
• 负责人: JUDITH G. RABKIN
• 金额: $ 35.47万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-10 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6148353
• 关键词: AIDS therapy; HIV infections; adrenocorticotropic hormone; antidepressants; binding proteins; cholesterol; clinical research; clinical trials; comorbidity; corticotropin releasing factor; cortisol; dehydroepiandrosterone; depression; emotions; gonadotropin releasing factor; hormone regulation /control mechanism; hormone therapy; human subject; human therapy evaluation; insulin; insulinlike growth factor; mental disorder chemotherapy; psychopharmacology; somatotropin; triglycerides

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.

这是抗抑郁药的双盲，安慰剂控制的临床试验 艾滋病毒+个体中DHEA的影响。次要目标将包括 确定DHEA是否具有合成代谢作用或雄激素 对入学受试者的影响。调查人员将考虑基本 受试者中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 在艾滋病毒感染的个体中使用DHEA的安全性。 该研究是一项八周的口服DHEA VS的双盲对照试验。 安慰剂有八周的毒品响应者维护阶段，16周 安慰剂非反应者提供的开放式治疗（八周之后 双盲试验）。他们提出了一个1：1随机化并预测114 注册的个人将完成八周的试用期。如果DHEA可以改善 抑郁症状，以及增加性欲和减少肌肉的损失 质量，然后调查人员将确定一项干预措施 适用于艾滋病毒感染的男性和女性的作用范围，即 实用，便宜且易于使用。 关于内分泌研究，研究人员将评估前体 和在口服该化合物之前和之后的DHEA代谢物， 并检查皮质醇，甘油三酸酯，胰岛素，胆固醇，生长的影响 激素，IGF-1和IGF-1结合蛋白。测试将在研究中进行 基线，第4和第8周，包括标准剂量ACTH，低剂量ACTH，CRF和 GNRH刺激测试以评估下丘脑 - 垂体 - 肾上腺和 DHEA给药之前和之后的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，性欲和身体的假定治疗作用 作品。