Lindner Center of HOPE, Mason, Ohio 45040, USA.
J Affect Disord. 2010 Jul;124(1-2):157-63. doi: 10.1016/j.jad.2009.11.014. Epub 2009 Dec 5.
There are no randomized, placebo-controlled data for quetiapine in outpatients with bipolar spectrum disorder (ambulatory BSD) and moderate-to-severe hypomanic or mild manic symptoms (hypomania/mild mania).
An 8-week, randomized, double-blind, placebo-controlled trial of quetiapine in ambulatory BSD with hypomanic/mild manic symptoms, defined operationally as a score of >or=3 but <5 on the mania subscale of the Clinical Global Impressions Scale Modified for Bipolar Illness (CGI-BP) at baseline and one prior study visit, at least 3 days but no more than 2 weeks apart. The primary outcome measure was the rate of change in the Young Mania Rating Scale score (YMRS).
During the 8-week study period, patients receiving quetiapine (average daily dose=232mg) had a marginally greater rate of reduction in mean total YMRS score than patients receiving placebo (p=0.06). Additionally, CGI-BP mania (p=0.01) and the CGI-BP overall (p<0.001) scores were significantly reduced and the CGI-depression score (p=0.08) was marginally reduced in the quetiapine group. Six (32%) quetiapine patients and 8 (40%) placebo patients did not complete the trial.
Small sample size and high attrition (36%).
Quetiapine was marginally more effective than placebo in reducing hypomanic/mild manic symptoms in ambulatory BSD as assessed by the YMRS. It was more effective than placebo in reducing manic symptoms and global bipolar symptoms as assessed by the CGI-BP. The drug's discontinuation rate was similar to placebo's. Controlled trials of quetiapine and other compounds with mood stabilizing properties in larger groups of ambulatory BSD patients with hypomanic/mild manic symptoms appear warranted.
目前尚无喹硫平治疗轻躁狂或轻躁狂发作患者的随机、安慰剂对照研究数据，这些患者属于双相情感障碍谱（门诊 BSD），存在中重度轻躁狂或轻度躁狂症状（轻躁狂/轻度躁狂）。
这是一项 8 周、随机、双盲、安慰剂对照试验，纳入了门诊 BSD 伴轻躁狂/轻度躁狂症状的患者，采用操作定义评估，即基线和之前的一次就诊时，杨氏躁狂量表（YMRS）躁狂分量表评分>3 分但<5 分，两次就诊时间至少间隔 3 天但不超过 2 周。主要疗效评估指标为 YMRS 评分变化率。
在 8 周的研究期间，接受喹硫平治疗的患者（平均日剂量为 232mg）的 YMRS 总分平均降低率显著大于接受安慰剂的患者（p=0.06）。此外，喹硫平组患者的临床总体印象-双相障碍量表（CGI-BP）躁狂评分（p=0.01）和 CGI-BP 总分（p<0.001）显著降低，CGI-抑郁评分（p=0.08）也有轻度降低。喹硫平组有 6 例（32%）和安慰剂组有 8 例（40%）患者未完成试验。
样本量小且脱落率高（36%）。
在评估 YMRS 时，喹硫平在减轻门诊 BSD 中轻躁狂/轻度躁狂症状方面比安慰剂更有效。与安慰剂相比，喹硫平在减轻躁狂症状和 CGI-BP 整体双相症状方面更有效。该药物的停药率与安慰剂相似。需要在更大样本量的门诊 BSD 伴轻躁狂/轻度躁狂症状患者中开展喹硫平及其他具有稳定情绪特性的化合物的对照试验。
