College of Medicine, University of South Florida, Tampa, FL 33613, USA.
Int Clin Psychopharmacol. 2012 Sep;27(5):239-48. doi: 10.1097/YIC.0b013e328356ac78.
The aim of this study was to assess patients' functioning and sleep quality during extended-release quetiapine fumarate (quetiapine XR) maintenance treatment. A double-blind, randomized-withdrawal maintenance study of quetiapine XR monotherapy was carried out in patients with major depressive disorder. Following 4-8 weeks of open-label quetiapine XR and 12-18 weeks of open-label quetiapine XR stabilization (50, 150, or 300 mg/day), eligible patients were randomized to quetiapine XR (50, 150, or 300 mg/day) or placebo. Secondary variables of the Sheehan Disability Scale (SDS) and the Pittsburgh Sleep Quality Index (PSQI) were used to assess functioning and sleep quality and are reported here. Quetiapine XR significantly maintained functioning versus placebo. Changes in the least squares means (LSM) from randomization in the SDS total scores were as follows: -0.45, quetiapine XR (P<0.05), versus 0.44, placebo. Quetiapine XR significantly maintained SDS domains 'social life/leisure' (-0.19; P<0.05) and 'family life/home responsibilities' (-0.22; P<0.05) versus placebo (0.13 and 0.10, respectively). Quetiapine XR significantly maintained sleep quality (LSM change in PSQI total scores: 0.06, quetiapine XR vs. 1.35, placebo; P<0.001), with five of seven PSQI components being significant for quetiapine XR versus placebo. In conclusion, quetiapine XR (50-300 mg/day) monotherapy better maintains overall functioning and sleep quality than placebo in patients with major depressive disorder.
本研究旨在评估富马酸喹硫平缓释片（quetiapine XR）维持治疗期间患者的功能和睡眠质量。在伴有重性抑郁障碍的患者中进行了富马酸喹硫平 XR 单药治疗的双盲、随机撤药维持研究。在 4-8 周的富马酸喹硫平 XR 开放标签治疗和 12-18 周的富马酸喹硫平 XR 稳定期（50、150 或 300mg/天）后，符合条件的患者被随机分配至富马酸喹硫平 XR（50、150 或 300mg/天）或安慰剂组。使用 Sheehan 残疾量表（SDS）和匹兹堡睡眠质量指数（PSQI）的次要变量来评估功能和睡眠质量，并在此报告。与安慰剂相比，富马酸喹硫平 XR 显著维持了功能。从随机分组时 SDS 总分的最小二乘均数（LSM）变化如下：-0.45，富马酸喹硫平 XR（P<0.05），与 0.44，安慰剂。与安慰剂相比（分别为 0.13 和 0.10），富马酸喹硫平 XR 显著维持 SDS 领域的“社会生活/休闲”（-0.19；P<0.05）和“家庭生活/家庭责任”（-0.22；P<0.05）。富马酸喹硫平 XR 显著维持睡眠质量（PSQI 总分的 LSM 变化：0.06，富马酸喹硫平 XR 与 1.35，安慰剂；P<0.001），七个 PSQI 成分中有五个在富马酸喹硫平 XR 与安慰剂相比有显著差异。总之，富马酸喹硫平 XR（50-300mg/天）单药治疗在伴有重性抑郁障碍的患者中比安慰剂更能维持整体功能和睡眠质量。
