Comprehensive Neuroscience, Atlanta, GA 30342, USA.
J Affect Disord. 2011 Jan;128(1-2):83-94. doi: 10.1016/j.jad.2010.06.031. Epub 2010 Aug 6.
Evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) once-daily monotherapy for patients with major depressive disorder (MDD).
In this 10-week, (8-week active treatment phase and 2-week drug-discontinuation/tapering phase), multicenter, parallel-group, placebo-controlled, double-blind, randomized, Phase III study (D1448C00003: Opal), patients initially received quetiapine XR 150 mg/day or placebo. At Week 2, inadequate responders (<20% reduction in MADRS total score) were up-titrated to 300 mg/day quetiapine XR or matching placebo for the final 6 weeks. Primary endpoint: change from randomization to Week 8 in MADRS total score. Secondary endpoints included: MADRS response (≥50% reduction in total score from randomization) and changes from randomization to Week 8 in HAM-D and CGI-S.
310 patients were randomized. At Week 8, quetiapine XR significantly reduced mean MADRS total score versus placebo (-16.49 vs -13.10, respectively; p<0.01). Mean MADRS score was significantly reduced by quetiapine XR versus placebo at Week 1 (p<0.05). MADRS response rates were significantly greater at Week 8 for quetiapine XR versus placebo (61.9% vs 48.0%, respectively; p<0.05). Significant changes in HAM-D total score and CGI-S were seen at Week 8 for quetiapine XR versus placebo. Withdrawal rates due to AEs were 9.9% and 2.6% for quetiapine XR and placebo, respectively. Common AEs (>10% any group during the randomized phase) for quetiapine XR and placebo, respectively were dry mouth (32.9% and 6.5%), sedation (21.7% and 1.9%), somnolence (20.4% and 5.2%), and headache (10.5% and 10.3%).
The study was not designed to compare quetiapine XR 150 mg/day and 300 mg/day; it was intended to reflect dose titration that might occur in clinical practice.
Quetiapine XR monotherapy is effective in patients with MDD, with symptom improvement seen as early as Week 1, and tolerability results consistent with the known profile of quetiapine.
评估富马酸喹硫平缓释片（喹硫平 XR）单药治疗对重性抑郁障碍（MDD）患者的疗效和耐受性。
这是一项为期 10 周的、多中心、平行分组、安慰剂对照、双盲、随机、III 期研究（D1448C00003：Opal），患者最初接受喹硫平 XR 150mg/天或安慰剂治疗。在第 2 周时，应答不足（MADRS 总分降低<20%）的患者将加量至喹硫平 XR 300mg/天或匹配的安慰剂，持续最后 6 周。主要终点：从随机化到第 8 周时 MADRS 总分的变化。次要终点包括：MADRS 应答（总分从随机化起降低≥50%）和从随机化到第 8 周时 HAM-D 和 CGI-S 的变化。
310 名患者被随机分组。在第 8 周时，与安慰剂相比，喹硫平 XR 显著降低了 MADRS 总分（分别为-16.49 与-13.10，p<0.01）。喹硫平 XR 与安慰剂相比，MADRS 评分在第 1 周就显著降低（p<0.05）。在第 8 周时，喹硫平 XR 的 MADRS 应答率显著高于安慰剂组（分别为 61.9%和 48.0%，p<0.05）。与安慰剂相比，在第 8 周时，HAM-D 总分和 CGI-S 也有显著变化。喹硫平 XR 和安慰剂组因不良事件而停药的比例分别为 9.9%和 2.6%。喹硫平 XR 和安慰剂组分别有>10%的患者出现的常见不良事件为口干（32.9%和 6.5%）、镇静（21.7%和 1.9%）、嗜睡（20.4%和 5.2%）和头痛（10.5%和 10.3%）。
该研究并非旨在比较喹硫平 XR 150mg/天和 300mg/天的疗效；其目的是反映可能在临床实践中出现的剂量滴定。
喹硫平 XR 单药治疗对 MDD 患者有效，症状改善早在第 1 周就可见，且耐受性结果与喹硫平的已知特征一致。
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