A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania
A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania
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DOI：
10.4088/jcp.v67n1003
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发表时间：
2006-10-01
影响因子：
5.3
通讯作者：
Saltarelli, Mario
中科院分区：
文献类型：
--
作者：
Bowden, Charles L.;Swann, Alan C.;Saltarelli, Mario
目的：评价异丙酚钠缓释片(Divalproex ER)在急性躁狂伴双相I型障碍、躁狂症或混合型躁狂症患者中的疗效和安全性(DSM-IV-TRR标准)。方法：377例患者按1：1比例随机分为两组，每组192例，其中安慰剂185例，双盲治疗21天。每日剂量开始为25 mg/kg，第3天增加500 mg，调整为丙戊酸盐血药浓度85~125 mU g/m L。采用躁狂评定量表(MRS)评定疗效。在盲目治疗期间，患者仍需住院至少15天。这项研究是在2003年4月至2004年5月进行的。结果：与安慰剂相比，接受异丙戊酸ER的患者在第5天的第一次治疗评级评估和第21天的所有后续评估中，MRS的改善明显更大(p=.013)。此外，在MRS中，接受异丙戊酸ER治疗的患者在MRS中取得至少50%改善的患者比例(48%)明显高于接受安慰剂治疗的患者(34%)(p=.012)。接受Divalproex ER治疗的患者有5项I-MRS项目的改善明显高于安慰剂：睡眠需求减少(p
Objective: The efficacy and safety of dival-proex sodium extended release (divalproex ER) were evaluated in patients hospitalized for acute mania associated with bipolar I disorder, manic or mixed type (DSM-IV-TR criteria).Method: Following screening and washout of psychotropic medications, 377 patients were randomly assigned in a 1:1 ratio to 21 days of double-blind treatment with divalproex ER (N = 192) or placebo (N = 185). Daily dosage was initiated at 25 mg/kg, increased 500 mg on day 3, and adjusted to serum valproate concentrations of 85 to 125 mu g/mL. The Mania Rating Scale (MRS) was, used to assess efficacy. Patients remained hospitalized at least 15 days during blinded treatment. The study was conducted from April 2003 to May 2004.Results: Improvement from baseline on the MRS was significantly greater among patients who received divalproex ER compared with placebo at the first on-treatment rating assessment, day 5, and all subsequent ratings through day 21 (p = .013). Furthermore, the proportion of patients achieving at least 50% improvement from baseline in MRS was significantly higher in patients receiving divalproex ER (48%) than in patients receiving placebo (34%) (p = .012). Five of the I I MRS items improved significantly more in patients receiving divalproex ER than placebo: less need for sleep (p