Suppes Trisha, Hirschfeld Robert M, Vieta Eduard, Raines Shane, Paulsson Björn
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX 75390-9121, USA.
World J Biol Psychiatry. 2008;9(3):198-211. doi: 10.1080/15622970701317265.
To investigate the efficacy and tolerability of quetiapine monotherapy for depressive episodes in patients with bipolar II disorder.
A post-hoc evaluation was conducted in 351 patients with bipolar II depression combined from two similarly designed double-blind, randomized, placebo-controlled, 8-week studies of quetiapine (300 or 600 mg/day) that included patients with bipolar I or II disorder (DSM-IV) exhibiting moderate to severe depression. The primary endpoint was change from baseline to week 8 in MADRS total score. Secondary endpoints included HAM-D, HAM-A, and CGI.
In patients with bipolar II disorder, improvement in mean MADRS total score from baseline was significantly greater with quetiapine 300 (n = 107) and 600 mg/day (n = 106) from the first assessment (week 1) through week 8 compared with placebo (n = 108). The mean change from baseline at week 8 for quetiapine 300 and 600 mg/day versus placebo was -17.1 and -17.9 versus -13.3 (P = 0.005 and P = 0.001 versus placebo), respectively. Change in HAM-D, HAM-A, and CGI were also significantly greater for quetiapine groups versus placebo. Common adverse events in the quetiapine groups included dry mouth, sedation, and somnolence.
Quetiapine demonstrated significant efficacy as monotherapy, compared with placebo, for the treatment of acute depressive episodes in bipolar II disorder.
探讨喹硫平单药治疗双相II型障碍抑郁发作的疗效和耐受性。
对351例双相II型抑郁症患者进行事后评估，这些患者来自两项设计相似的双盲、随机、安慰剂对照、为期8周的喹硫平（300或600毫克/天）研究，研究对象包括患有中度至重度抑郁症的双相I型或II型障碍（DSM-IV）患者。主要终点是从基线到第8周MADRS总分的变化。次要终点包括汉密尔顿抑郁量表（HAM-D）、汉密尔顿焦虑量表（HAM-A）和临床总体印象量表（CGI）。
在双相II型障碍患者中，与安慰剂组（n = 108）相比，从首次评估（第1周）到第8周，喹硫平300毫克/天组（n = 107）和600毫克/天组（n = 106）的MADRS总分从基线的改善显著更大。喹硫平300毫克/天组和600毫克/天组在第8周相对于安慰剂组从基线的平均变化分别为-17.1和-17.9，而安慰剂组为-13.3（与安慰剂组相比，P = 0.005和P = 0.001）。喹硫平组在HAM-D、HAM-A和CGI方面的变化也显著大于安慰剂组。喹硫平组常见的不良事件包括口干、镇静和嗜睡。
与安慰剂相比，喹硫平作为单药治疗双相II型障碍急性抑郁发作具有显著疗效。
