OPEN-LABEL TREATMENT OF SCHIZOFFECTIVE DISORDER USING MIFEPRISTONE

使用米非司酮治疗精神分裂症的开放标签治疗

• 批准号: 7375188
• 负责人: ALAN F. SCHATZBERG
• 金额: $ 1.82万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375188
• 关键词: OPEN; LABEL; TREATMENT; SCHIZOFFECTIVE; DISORDER

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study proposes using Mifepristone on a compassionate use basis for patients diagnosed with either schizoaffective disorder or major depression with psychotic features. In screening potential patients for our previous studies, we have encountered a significant number who decline study participation because they could not be assured that they would receive active medication. In addition, past participants in our current Mifepristone-use study have expressed interest in receiving Mifepristone as part of an open-label clinical drug trial. Although we feel that double-blind, placebo-controlled studies are the "gold standard" to measure efficacy, we also feel that patients with severe affective psychoses may be helped significantly by Mifepristone. The data obtained in an open-label study will still be useful. Our aim is to test the hypothesis that Mifepristone will rapidly improve psychosis and altered cognition and mood in individuals diagnosed with either schizoaffective disorder or psychotic major depression. Research questions to be clarified by the data: a. Will Mifepristone rapidly improve the psychosis, altered cognition, and mood-component of individuals diagnosed with either schizoaffective disorder or psychotic major depression? b. Do levels of cortisol, adenocorticotropic hormone (ACTH), and homovanillic acid (HVA) change (i.e., demonstrate a post-treatment decrease from baseline levels) in these subjects after being treated with Mifepristone?

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究建议使用米非司酮的同情使用的基础上诊断为情感性精神障碍或抑郁症与精神病性功能的患者。在筛选我们先前研究的潜在患者时，我们遇到了大量拒绝参与研究的患者，因为他们不能保证他们会接受活性药物治疗。此外，在我们目前的米非司酮使用研究的过去参与者表示有兴趣接受米非司酮作为开放标签临床药物试验的一部分。 虽然我们认为双盲、安慰剂对照研究是衡量疗效的“金标准”，但我们也认为，米非司酮对严重情感性精神病患者可能有显著帮助。在开放标签研究中获得的数据仍然有用。 我们的目的是检验米非司酮是否能迅速改善情感障碍或精神病性抑郁症患者的精神状态，改变认知和情绪。 需要通过数据澄清的研究问题：a.米非司酮能否迅速改善情感障碍或精神病性抑郁症患者的精神病、认知改变和情绪成分？B.皮质醇、促肾上腺皮质激素（ACTH）和高香草酸（HVA）的水平是否发生变化（即，显示治疗后较基线水平下降）。