Trivedi Madhukar H, Rush A John, Wisniewski Stephen R, Nierenberg Andrew A, Warden Diane, Ritz Louise, Norquist Grayson, Howland Robert H, Lebowitz Barry, McGrath Patrick J, Shores-Wilson Kathy, Biggs Melanie M, Balasubramani G K, Fava Maurizio
Department of Psychiatry, University of Texas Southwestern Medical Center, Exchange Park Express, American General Tower, 6363 Forest Park Rd., Suite 1300, Dallas, TX 75390-9119, USA.
Am J Psychiatry. 2006 Jan;163(1):28-40. doi: 10.1176/appi.ajp.163.1.28.
Selective serotonin reuptake inhibitors (SSRIs) are widely used to treat depression, but the rates, timing, and baseline predictors of remission in "real world" patients are not established. The authors' primary objectives in this study were to evaluate the effectiveness of citalopram, an SSRI, using measurement-based care in actual practice, and to identify predictors of symptom remission in outpatients with major depressive disorder.
This clinical study included outpatients with major depressive disorder who were treated in 23 psychiatric and 18 primary care "real world" settings. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks. The clinicians were assisted by a clinical research coordinator in the application of measurement-based care, which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures. Remission was defined as an exit score of <or=7 on the 17-item Hamilton Depression Rating Scale (HAM-D) (primary outcome) or a score of <or=5 on the 16-item Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) (secondary outcome). Response was defined as a reduction of >or=50% in baseline QIDS-SR score.
Nearly 80% of the 2,876 outpatients in the analyzed sample had chronic or recurrent major depression; most also had a number of comorbid general medical and psychiatric conditions. The mean exit citalopram dose was 41.8 mg/day. Remission rates were 28% (HAM-D) and 33% (QIDS-SR). The response rate was 47% (QIDS-SR). Patients in primary and psychiatric care settings did not differ in remission or response rates. A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment. Participants who were Caucasian, female, employed, or had higher levels of education or income had higher HAM-D remission rates; longer index episodes, more concurrent psychiatric disorders (especially anxiety disorders or drug abuse), more general medical disorders, and lower baseline function and quality of life were associated with lower HAM-D remission rates.
The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials. The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results.
选择性5-羟色胺再摄取抑制剂（SSRI）被广泛用于治疗抑郁症，但“现实世界”中患者的缓解率、缓解时间及缓解的基线预测因素尚未明确。作者开展本研究的主要目的是在实际临床中采用基于测量的护理方法评估SSRI之一的西酞普兰的疗效，并确定重度抑郁症门诊患者症状缓解的预测因素。
本临床研究纳入了在23个精神科和18个初级保健“现实世界”机构接受治疗的重度抑郁症门诊患者。患者接受临床医生开具的灵活剂量的西酞普兰治疗，为期14周。临床研究协调员协助临床医生应用基于测量的护理方法，包括在每次治疗访视时常规测量症状和副作用，并使用一本治疗手册，该手册描述了如何根据这些测量结果确定何时以及如何调整药物剂量。缓解定义为17项汉密尔顿抑郁量表（HAM-D）的退出分数≤7分（主要结局）或16项抑郁症状快速自评量表（QIDS-SR）的分数≤5分（次要结局）。反应定义为基线QIDS-SR分数降低≥50%。
分析样本中的2876名门诊患者中，近80%患有慢性或复发性重度抑郁症；大多数患者还伴有多种共病的普通内科和精神科疾病。西酞普兰的平均退出剂量为41.8毫克/天。缓解率分别为28%（HAM-D）和33%（QIDS-SR）。反应率为47%（QIDS-SR）。初级保健机构和精神科机构的患者在缓解率或反应率方面没有差异。在研究结束时达到反应或缓解的参与者中，很大一部分是在治疗8周及以后实现的。白人、女性、就业、或教育水平或收入较高的参与者HAM-D缓解率较高；病程较长、并发更多精神障碍（尤其是焦虑症或药物滥用）、更多普通内科疾病以及较低的基线功能和生活质量与较低的HAM-D缓解率相关。
在这个具有大量轴I和轴III共病的高度可推广样本中，反应率和缓解率与8周疗效试验中的情况非常相似。系统使用易于实施的基于测量的护理程序可能有助于取得这些结果。
