MOOD EFFECT OF TESTOSTERONE VS FLUOXETINE IN HIV ILLNESS

描述（申请人摘要）：在此竞争性延续中 应用程序，主要目标是评估抗抑郁作用的 睾酮与氟西汀在双盲随机安慰剂中的比较 对照临床试验的艾滋病毒阳性患者的抑郁症作为 以及性腺功能减退的临床症状 在睾丸激素资助的前两年，研究人员 在12周内治疗HIV阳性男性性腺功能减退的临床症状 开放试验，随后是6周双盲安慰剂对照 以性欲改善为主要结局标准的中止试验。 在停药阶段，79%（26/33）的患者随机接受睾酮治疗 维持反应，而安慰剂组为15%（5/34）。 这个样本中有27名男性患有重度抑郁症。 其中，21（78） %）在开放治疗8周后情绪有显著改善。 在正在进行的NIMH支持的氟西汀安慰剂对照试验中，36 患有重性抑郁症的患者已经用氟西汀治疗， 与安慰剂进行双盲随机试验。 的应答率 氟西汀和安慰剂分别为75%和45%。 综合起来，这些结果表明了一项旨在 直接比较睾酮、氟西汀和 安慰剂 设计将是一项为期8周的双盲3臂睾酮研究 注射剂（和安慰剂胶囊）、氟西汀（和安慰剂注射剂），以及 安慰剂（安慰剂注射剂和安慰剂胶囊）。 调查人员 建议2：1：1随机化，140例患者（70：35：35）完成 8-周审判 睾丸激素手臂是最大的，因为他们寻求 确定抗抑郁作用是否继发于或独立于 雄激素（增加性欲）或合成代谢（增加体重和/或肌肉 质量）效应。 试验结束后，治疗将继续进行4个月。 几个月来评估长期患者接受度、副作用和安全性， 使用HIV RNA病毒载量来衡量免疫效果。 其目的是确定 一个实用的，便宜的，对社区环境有用的治疗。

DESCRIPTION (Applicant's Abstract): In this competitive continuation application, the primary goal is to evaluate the antidepressant effects of testosterone compared to fluoxetine in a double-blind randomized placebo controlled clinical trial for HIV-positive patients with major depression as well as clinical symptoms of hypogonadism. In the first 2 years of the ongoing testosterone grant, the investigators treated HIV-positive men with clinical symptoms of hypogonadism in a 12-week open trial followed by a 6-week double-blind placebo controlled discontinuation trial with improved libido as the major outcome criterion. In the discontinuation phase, 79 percent (26/33) randomized to testosterone maintained response, compared to 15 percent (5/34) for placebo. Twenty-seven men in this sample had major depression. Of these, 21 (78 percent) had significantly improved mood after 8 weeks of open treatment. In the ongoing NIMH-supported placebo controlled trial of fluoxetine, 36 patients with major depression have been treated with fluoxetine, and 22 with placebo in a double-blind randomized trial. Response rates to fluoxetine and placebo respectively have been 75 percent and 45 percent. The results, taken together, suggest the value of a study designed to directly compare antidepressant effects of testosterone, fluoxetine, and placebo. The design will be an 8-week double blind 3-arm study of testosterone injections (and placebo capsules), fluoxetine (and placebo injections), and placebo (placebo injections and placebo capsules). The investigators propose a 2:1:1 randomization with 140 patients (70:35:35) completing the 8-week trial. The testosterone arm is the largest since they seek to determine whether an antidepressant effect is secondary to or independent of androgenic (increased libido) or anabolic (increased weight and/or muscle mass) effects. After this trial, treatment will be continued for another 4 months to assess longer-term patient acceptance, side effects, and safety, using HIV RNA viral load to gauge immune effects. The intent is to identify a practical, inexpensive, useful treatment for community settings.