Department of Psychiatry, University of Toronto, Toronto, Ontario.
Can J Psychiatry. 2010 Mar;55(3):126-35. doi: 10.1177/070674371005500303.
The Sequenced Treatment Alternatives to Relieve Depression (STARD) trial is the largest open-label, pragmatic trial that has been undertaken to examine the treatment of major depressive disorder. At a cost of US$35 million over 6 years, STARD sought to test the effectiveness both of pharmacotherapy and of cognitive therapy, and to ascertain whether certain treatments are more optimal after one or more failed trials.
Patients (n = 2876) who presented to either a psychiatry or family practice setting seeking treatment for depression were included in the STARD analysis. In the 4 levels of STARD, patients were randomized to various treatment monotherapies, combinations, or augmentation strategies. The primary outcome was remission, based on the Hamilton Depression Rating Scale. Secondary outcomes were response, as measured by clinician and patient self-report as well as various measures of patients' level of function and (or) quality of life.
Remission rates for treatment levels 1 to 2 and 3 to 4 were 18% to 30% and 7% to 25%, respectively. There was no difference in effectiveness between any treatments at any treatment level. Patients with longer index episodes, more concurrent psychiatric or general medical disorders, and (or) lower measures of baseline function were less likely to achieve remission. There were no major differences between outcomes in patients treated in primary, compared with specialist care, nor were there significant differences between depression rating scores obtained through clinician ratings, compared with self-report.
Results of the STAR*D trial have shed important light on the effectiveness of current treatment strategies for patients with depression.
缓解抑郁症的序贯治疗选择(STAR*D)试验是迄今为止最大规模的开放性、实用性试验,旨在检验治疗重度抑郁症的方法。该试验历时 6 年,耗资 3500 万美元,旨在检验药物治疗和认知疗法的有效性,以及确定在经过一次或多次失败的试验后,哪些治疗方法更为理想。
在 STARD 分析中,共纳入了 2876 名在精神病学或家庭医学机构就诊、寻求抑郁症治疗的患者。在 STARD 的 4 个阶段中,患者被随机分配到各种单一疗法、联合疗法或增效策略的治疗中。主要结局是基于汉密尔顿抑郁评定量表(Hamilton Depression Rating Scale)评估的缓解率。次要结局包括反应,通过临床医生和患者自我报告以及患者功能水平和(或)生活质量的各种测量来评估。
治疗水平 1 至 2 和 3 至 4 的缓解率分别为 18%至 30%和 7%至 25%。在任何治疗水平,任何治疗之间的疗效均无差异。指数发作时间较长、同时存在更多精神或一般医学疾病、以及(或)基线功能测量值较低的患者,缓解的可能性较低。在初级保健与专科保健治疗的患者之间,以及在通过临床医生评估与自我报告获得的抑郁评分之间,结果均无重大差异。
STAR*D 试验的结果为当前针对抑郁症患者的治疗策略的有效性提供了重要的启示。