Rhodiola rosea Therapy of Major Depressive Disorder

红景天治疗重度抑郁症

• 批准号: 7896240
• 负责人: JAY D AMSTERDAM
• 金额: $ 23.99万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7896240
• 关键词: Accounting; Adverse event; Affect; American; Animals; Antidepressive Agents; Arts; Botanicals; Cardiovascular Diseases; Clinical Trials; Comorbidity; Complementary and alternative medicine; Crassulaceae; Development; Diagnostic and Statistical Manual; Disease; Dose; Double-Blind Method; Economics; Emotional; Enrollment; Expenditure; Family; Folk Remedy; Frequencies; Future; Grant; Hamilton Rating Scale for Depression; Healthcare; Human; Immigrant; Immunologics; Individual; Infection; Major Depressive Disorder; Malignant Neoplasms; Measures; Medical; Mental Depression; Moods; National Center for Complementary and Alternative Medicine; Neurosecretory Systems; Neurotransmitters; Occupational; Outcome Measure; Patients; Performance; Pharmacotherapy; Placebo Control; Placebos; Population; Prevalence; Preventive; Property; Psyche structure; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Recording of previous events; Relative (related person); Research; Research Personnel; Roseroot; Safety; Serious Adverse Event; Sertraline; Severities; Symptoms; System; Techniques; Time; Toxic effect; Uninsured; base; burden of illness; comparative; cost; depressive symptoms; dietary supplements; disability; dosage; efficacy trial; functional disability; meetings; nervous system disorder; primary outcome; public health relevance; social; social stigma; suicidal morbidity

DESCRIPTION (provided by applicant): This exploratory grant, entitled Rhodiola rosea Therapy of Major Depressive Disorder (MDD), is submitted to the NCCAM under PAR-08-135 to perform human safety and efficacy trials of complementary and alternative medicine (CAM) in the domain of biologically-based practices. We will study the antidepressant action of R. rosea in patients with MDD. Depression affects more than a billion people world wide, and is now recognized as one of the most disabling medical conditions. It accounts for more than 11% of the total disease burden worldwide, and can result in devastating consequences and functional impairment exceeded only by that of cancer and cardiovascular disease. It results in substantial social, occupational, and personal disability and in increased medical co-morbidity and death by suicide. It is considered to be a multi-system disorder characterized by neurotransmitter, neuroendocrine, immunologic, and autonomic disturbances. Although the development of antidepressant drug therapy has simplified the treatment of MDD, a substantial segment of the world's population remains untreated for economic, cultural, or personal reasons. As a result, many individuals seek CAM for relief of their symptoms. The identification of effective CAM therapies for MDD is of public health relevance. R. rosea belongs to the family Crassulaceae, and has a long history as a folk remedy for enhancing physical and emotional endurance. Its adaptogen, or preventive, properties have also led to its use in treating cancer, infection, depression, and other nervous system disorders. Several animal and human studies suggest that R. rosea may have antidepressant properties. For specific aim #1, we will ask: Is R. rosea a safe and effective short-term therapy (vs. sertraline and placebo) for patients with MDD?" To answer this question, patients meeting DSM IV criteria for mild to moderate MDD will be enrolled in a 12-week, randomized, double- blind, placebo-controlled, parallel group, dose-escalation study of R. rosea extract 340-1,360 mg daily vs. sertraline 50-200 mg daily. The primary outcome measure will be change over time in the 17-item Hamilton Depression Rating score. We hypothesize that R. rosea will have superior efficacy vs. placebo and comparable efficacy vs. sertraline. For specific aim #2, we will ask: Does R. rosea therapy result in a favorable tolerability and quality of life (QOL) profile vs. sertraline and placebo? To answer this question, we will obtain safety and QOL measures across treatment conditions that include: (i) frequency, duration, and severity of adverse events, (ii) frequency of serious adverse events, (iii) frequency of dosage reduction, (iv) frequency of treatment discontinuation, and (v) QOL and sexual performance measures. We hypothesize that R. rosea will have a superior tolerability profile vs. sertraline, and similar tolerability vs. placebo. We further hypothesize that R. rosea will have superior QOL and sexual performance ratings vs. sertraline and placebo. Results from this study will be used to inform future research hypotheses and to estimate the effect size necessary to power a future, large scale study. PUBLIC HEALTH RELEVANCE: This application comports with the public health intent of PAR-08-135 to perform clinical trials in humans on the safety, efficacy, toxicity, and optimal dosage of biologically-based complementary and alternative medicine (CAM) therapies. It is an exploratory study of a new therapy for Major Depressive Disorder (MDD), a debilitating illness of uncertain cause. This study will use state-of-the-art clinical trial techniques to evaluate the safety, efficacy, and optimal dosage of Rhodiola rosea in patients with mild to moderate MDD. Results from this study will be used to inform future research hypotheses and to estimate the effect size necessary for conducting a future, large scale CAM study.

描述（由申请人提供）：这项名为红景天治疗重度抑郁症 (MDD) 的探索性资助，根据 PAR-08-135 提交给 NCCAM，用于在以下国家进行补充和替代医学 (CAM) 的人体安全性和有效性试验：基于生物学的实践领域。我们将研究玫瑰红对重度抑郁症患者的抗抑郁作用。抑郁症影响着全世界超过十亿人，现在被认为是最严重的疾病之一。它占全球总疾病负担的 11% 以上，可导致毁灭性后果和功能损害，仅次于癌症和心血管疾病。它会导致严重的社会、职业和个人残疾，并增加医疗并发症和自杀死亡。它被认为是一种以神经递质、神经内分泌、免疫和自主神经紊乱为特征的多系统疾病。尽管抗抑郁药物疗法的发展简化了重度抑郁症的治疗，但由于经济、文化或个人原因，世界上很大一部分人口仍未得到治疗。因此，许多人寻求 CAM 来缓解症状。确定针对 MDD 的有效 CAM 疗法具有公共卫生相关性。玫瑰花属于景天科，作为增强身体和情绪耐力的民间疗法有着悠久的历史。它的适应原或预防特性也导致其用于治疗癌症、感染、抑郁症和其他神经系统疾病。多项动物和人类研究表明，玫瑰红可能具有抗抑郁特性。对于具体目标#1，我们会问：玫瑰红对于 MDD 患者来说是一种安全有效的短期疗法（相对于舍曲林和安慰剂）吗？”为了回答这个问题，满足 DSM IV 轻度至中度 MDD 标准的患者将参加一项为期 12 周、随机、双盲、安慰剂对照、平行组、剂量递增研究，研究对象为玫瑰红提取物每天 340-1,360 毫克与舍曲林每天 50-200 毫克，主要结果指标将随着时间的推移在 17 项汉密尔顿抑郁评分中发生变化，我们假设 R.rosea 的疗效优于安慰剂，且与舍曲林的疗效相当。 ，我们会问：与舍曲林和安慰剂相比，红玫瑰疗法是否会产生良好的耐受性和生活质量（QOL）？为了回答这个问题，我们将获得跨治疗条件的安全性和生活质量（QOL）衡量标准：包括：(i) 不良事件的频率、持续时间和严重程度，(ii) 严重不良事件的频率，(iii) 剂量减少的频率，(iv) 停止治疗的频率，以及 (v) 生活质量和性能力指标。我们假设红玫瑰比舍曲林具有更好的耐受性，并且与安慰剂相比具有相似的耐受性。我们进一步假设，与舍曲林和安慰剂相比，红玫瑰具有更高的生活质量和性表现评级。这项研究的结果将用于为未来的研究假设提供信息，并估计为未来大规模研究提供动力所需的效应大小。 公共健康相关性：本申请符合 PAR-08-135 的公共健康意图，即对基于生物学的补充和替代医学 (CAM) 疗法的安全性、有效性、毒性和最佳剂量进行人体临床试验。这是一项针对重度抑郁症（MDD）新疗法的探索性研究，重度抑郁症是一种原因不明的使人衰弱的疾病。这项研究将使用最先进的临床试验技术来评估红景天对轻度至中度 MDD 患者的安全性、有效性和最佳剂量。这项研究的结果将用于为未来的研究假设提供信息，并估计进行未来大规模 CAM 研究所需的效应大小。