What Did STAR*D Teach Us? Results From a Large-Scale, Practical, Clinical Trial for Patients With Depression
What Did STAR*D Teach Us? Results From a Large-Scale, Practical, Clinical Trial for Patients With Depression
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DOI：
10.1176/ps.2009.60.11.1439
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发表时间：
2009-11-01
影响因子：
3.8
通讯作者：
Rush, A. John
中科院分区：
文献类型：
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作者：
Gaynes, Bradley N.;Warden, Diane;Rush, A. John
作者提供了缓解抑郁症的序贯治疗替代方案（星星 *D）研究（www.star-d.org）的概述，这是一项大规模的实用临床试验，旨在确定几种治疗方法中哪一种是最有效的“下一步”，用于那些症状没有缓解或不能耐受初始治疗的重度抑郁症患者，如果需要，随后的治疗。入选标准定义广泛且具有包容性，患者从精神科和初级保健诊所入组。所有参与者都开始服用西酞普兰，并由诊所医生进行管理，他们在12周内进行了5次随访，遵循算法指导的急性期治疗。在每个序列结束时，抑郁症尚未完全缓解的患者有资格参加随后的随机试验，最多三项临床试验。总体而言，研究诊所的缓解率低于预期，表明大多数患者需要采取几个步骤来实现缓解。对于那些在一次或多次积极的药物试验后抑郁症没有缓解的患者，没有明确的药物“赢家”。当初始抗抑郁药治疗失败时，转换和增强似乎都是合理的选择，尽管这两种策略无法直接比较。此外，在两次强有力的药物试验后缓解的可能性大大降低，缓解可能需要更复杂的药物治疗方案，现有的证据基础相当薄弱。星星 *D证明了在临床试验中纳入更多真实世界的患者是可行的，也是有益的。政策影响的研究结果，以及研究的局限性，进行了讨论。（精神病学服务60：1439-1445，2009）
The authors provide an overview of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study (www.star-d.org), a large-scale practical clinical trial to determine which of several treatments are the most effective "next-steps" for patients with major depressive disorder whose symptoms do not remit or who cannot tolerate an initial treatment and, if needed, ensuing treatments. Entry criteria were broadly defined and inclusive, and patients were enrolled from psychiatric and primary care clinics. All participants began on citalopram and were managed by clinic physicians, who followed an algorithm-guided acute-phase treatment through five visits over 12 weeks. At the end of each sequence, patients whose depression had not fully remitted were eligible for subsequent randomized trials in a sequence of up to three clinical trials. In general, remission rates in the study clinics were lower than expected, suggesting the need for several steps to achieve remission for most patients. There was no clear medication "winner" for patients whose depression did not remit after one or more aggressive medication trials. Both switching and augmenting appeared to be reasonable options when an initial antidepressant treatment failed, although these two strategies could not be directly compared. Further, the likelihood of remission after two vigorous medication trials substantially decreased, and remission would likely require more complicated medication regimens for which the existing evidence base is quite thin. STAR*D demonstrated that inclusion of more real-world patients in clinical trials is both feasible and informative. Policy implications of the findings, as well as the study's limitations, are discussed. (Psychiatric Services 60: 1439-1445, 2009)