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首页> 外文期刊>The journal of clinical psychiatry >Olanzapine-divalproex combination versus divalproex monotherapy in the treatment of bipolar mixed episodes: a double-blind, placebo-controlled study.
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Olanzapine-divalproex combination versus divalproex monotherapy in the treatment of bipolar mixed episodes: a double-blind, placebo-controlled study.

机译：奥氮平-divalproex联合双丙戊酸钠单药治疗双相混合性发作：一项双盲，安慰剂对照研究。

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OBJECTIVE: This 6-week, randomized, double-blind, placebo-controlled trial used simultaneous depression and mania criteria to compare a single mood stabilizer, divalproex, with and without adjunctive olanzapine in patients with bipolar I disorder experiencing acute mixed episodes. METHOD: Two hundred two adults, aged 18 to 60 years, who met DSM-IV-TR criteria for bipolar disorder with a current mixed episode and had been taking divalproex for >or=14 days at levels of 75 to 125 microg/mL with inadequate efficacy (21-item Hamilton Depression Rating Scale [HDRS-21] and Young Mania Rating Scale [YMRS] scores >or=16) were randomly assigned to olanzapine 5 to 20 mg/d versus placebo augmentation. HDRS-21, YMRS, Clinical Global Impressions for Bipolar Disorder (CGI-BP), hospitalizations, concomitant medications, and adverse events were assessed. Comparisons included changes in both HDRS-21 and YMRS (primary outcome measure), time to partial response and time to response, CGI-BP improvement, hospitalizations, and safety (secondary outcome measures). The study was conducted from December 2006 to February 2008. RESULTS: Mean (SD) baseline HDRS-21 and YMRS scores were 22.2 (4.5) and 20.9 (4.4), respectively, with 59% female and 51% white subjects. Mean +/- SE score changes from baseline across the 6-week treatment period for adjunctive olanzapine (n = 100) versus adjunctive placebo (n = 101) arms, respectively, were -9.37 +/- 0.55 versus -7.69 +/- 0.54, P = .022, on the HDRS-21 and -10.15 +/- 0.44 versus -7.68 +/- 0.44 P < .001, on the YMRS. Mean +/- SE score changes from baseline to last observation carried forward for CGI-BP measures were -1.34 +/- 0.11 for adjunctive olanzapine versus -1.06 +/- 0.11 for adjunctive placebo, P = .056. Time to partial response (>or=25% HDRS-21 and YMRS decreases, median 7 versus 14 days) and time to response (>or=50% HDRS-21 and YMRS decreases, median 25 versus 49 days) were significantly shorter with adjunctive olanzapine. Increases in weight (total and >or=7%) and fasting blood glucose were significantly greater with adjunctive olanzapine. CONCLUSION: Adjunctive olanzapine yielded greater and earlier reduction of manic and depressive symptoms in mixed-episode patients with inadequate response to at least 2 weeks of divalproex. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00402324.
机译：目的：这项为期6周，随机，双盲，安慰剂对照的试验使用同时抑郁和躁狂症的标准，比较了患有和患有急性躁狂发作的双相I型障碍患者的单种情绪稳定剂divalproex（含或不含奥氮平）。方法：22名成年人，年龄18至60岁，符合双相情感障碍的DSM-IV-TR标准，目前混合发作，并以75至125 microg / mL的水平服用divalproex≥14天。疗效不佳（21项汉密尔顿抑郁量表[HDRS-21]和年轻躁狂症量表[YMRS]得分>或= 16）被随机分配给奥氮平5至20 mg / d与安慰剂组。评估了HDRS-21，YMRS，双相情感障碍的临床总体印象（CGI-BP），住院，伴随用药和不良事件。比较包括HDRS-21和YMRS（主要结果指标），部分缓解时间和响应时间，CGI-BP改善​​，住院和安全性（次要结果指标）的变化。该研究于2006年12月至2008年2月进行。结果：HDRS-21和YMRS基线的平均（SD）得分分别为22.2（4.5）和20.9（4.4），其中59％的女性和51％的白人受试者。奥氮平（n = 100）与安慰剂（n = 101）辅助组在6周治疗期间的平均+/- SE得分变化分别为-9.37 +/- 0.55和-7.69 +/- 0.54在HDRS-21上为P = .022，在YMRS上为-10.15 +/- 0.44，而对于-7.68 +/- 0.44 P <.001。从基线到最后一次观察到的CGI-BP测量值的平均+/- SE得分变化对于辅助性奥氮平为-1.34 +/- 0.11，对于辅助性安慰剂为-1.06 +/- 0.11，P = .056。达到部分缓解的时间（>或= 25％HDRS-21和YMRS减少，中位数为7天比14天）和响应时间（>或= 50％的HDRS-21和YMRS减少，中位数为25天与49天）辅助性奥氮平。辅助性奥氮平的体重增加（总计或≥7％）和空腹血糖显着增加。结论：奥氮平辅助治疗在至少对divalproex至少2周反应不足的混合发作患者中产生了更大，更早的躁狂和抑郁症状缓解。试验注册：clinicaltrials.gov标识符：NCT00402324。

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