Perahia David G S, Quail Deborah, Desaiah Durisala, Corruble Emmanuelle, Fava Maurizio
Lilly Research Centre, Windlesham, Surrey, UK.
J Clin Psychiatry. 2008 Jan;69(1):95-105. doi: 10.4088/jcp.v69n0113.
To compare 2 methods of switching selective serotonin reuptake inhibitor (SSRI) non-responders or partial responders to duloxetine.
Adult outpatients with DSM-IV major depressive disorder, a Hamilton Rating Scale for Depression (HAM-D(17)) total score of >or= 15, and a Clinical Global Impressions-Severity of Illness score of >or= 3 despite at least 6 weeks of SSRI treatment were randomly assigned to either abrupt discontinuation of SSRI immediately followed by initiation of duloxetine (direct switch [DS]; N = 183) or tapered discontinuation of SSRI over 2 weeks and simultaneous administration of duloxetine (start-taper switch [STS]; N = 185). Efficacy, safety, and tolerability outcomes associated with these 2 switch methods were compared following switch and after 10 weeks of duloxetine treatment. The study was conducted from August 2004 to March 2006.
There was a significant improvement in depressive symptom severity in both switch groups as measured by mean change in HAM-D(17) total score (p <or= .001), but no difference between the switch groups (-10.23 DS vs. -10.49 STS). Criteria for noninferiority of the DS group to the STS group, which was the primary objective of the study, were met. Response rates (54.4% DS vs. 59.6% STS), remission rates (35.7% DS vs. 37.2% STS), and other secondary outcome measures were similar for both switch groups. Few patients discontinued the study due to adverse events (6.6% DS vs. 3.8% STS). Headache, dry mouth, and nausea were the most frequently reported adverse events in both switch groups.
Switch to duloxetine was associated with significant improvements in both emotional and painful physical symptoms of depression and was well tolerated and safe, regardless of which of the switch methods was used.
clinicaltrials.gov Identifier: NCT00191932.
比较将选择性5-羟色胺再摄取抑制剂（SSRI）无反应者或部分反应者换用度洛西汀的两种方法。
患有DSM-IV重度抑郁症的成年门诊患者，汉密尔顿抑郁量表（HAM-D(17)）总分≥15，且尽管接受了至少6周的SSRI治疗，但临床总体印象-疾病严重程度评分≥3，被随机分配至立即停用SSRI并随后开始使用度洛西汀（直接换药[DS]；N = 183）或在2周内逐渐停用SSRI并同时给予度洛西汀（起始-逐渐减量换药[STS]；N = 185）。比较这两种换药方法在换药后及度洛西汀治疗10周后的疗效、安全性和耐受性结果。该研究于2004年8月至2006年3月进行。
通过HAM-D(17)总分的平均变化衡量，两个换药组的抑郁症状严重程度均有显著改善（p≤.001），但换药组之间无差异（DS组为-10.23，STS组为-10.49）。满足了DS组不劣于STS组这一研究主要目标的非劣效性标准。两个换药组的缓解率（DS组为54.4%，STS组为59.6%）、治愈率（DS组为35.7%，STS组为37.2%）及其他次要结果指标相似。很少有患者因不良事件而退出研究（DS组为6.6%，STS组为3.8%）。头痛、口干和恶心是两个换药组中最常报告的不良事件。
无论使用哪种换药方法，换用度洛西汀均与抑郁的情绪和疼痛性躯体症状的显著改善相关，且耐受性良好、安全性高。
clinicaltrials.gov标识符：NCT00191932。
