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GERI-BD: A Randomized Double-Blind Controlled Trial of Lithium and Divalproex in the Treatment of Mania in Older Patients With Bipolar Disorder
American Journal of Psychiatry ( IF 15.1 ) Pub Date : 2017-08-04 , DOI: 10.1176/appi.ajp.2017.15050657
Robert C Young 1 , Benoit H Mulsant 1 , Martha Sajatovic 1 , Ariel G Gildengers 1 , Laszlo Gyulai 1 , Rayan K Al Jurdi 1 , John Beyer 1 , Jovier Evans 1 , Samprit Banerjee 1 , Rebecca Greenberg 1 , Patricia Marino 1 , Mark E Kunik 1 , Peijun Chen 1 , Marna Barrett 1 , Herbert C Schulberg 1 , Martha L Bruce 1 , Charles F Reynolds 1 , George S Alexopoulos 1 , 1
Affiliation  

Objective:

Clinicians treating older patients with bipolar disorder with mood stabilizers need evidence from age-specific randomized controlled trials. The authors describe findings from a first such study of late-life mania.

Method:

The authors compared the tolerability and efficacy of lithium carbonate and divalproex in 224 inpatients and outpatients age 60 or older with bipolar I disorder who presented with a manic, hypomanic, or mixed episode. Participants were randomly assigned, under double-blind conditions, to treatment with lithium (target serum concentration, 0.80–0.99 mEq/L) or divalproex (target serum valproate concentration, 80–99 μg/mL) for 9 weeks. Participants with an inadequate response after 3 weeks received open adjunctive risperidone. The authors hypothesized that divalproex would be better tolerated and more efficacious than lithium. Tolerability was assessed based on a measure of sedation and on the proportions of participants achieving target concentrations. Efficacy was assessed with the Young Mania Rating Scale (YMRS).

Results:

Attrition rates were similar for lithium and divalproex (14% and 18% at week 3 and 51% and 44% at week 9, respectively). The groups did not differ significantly in sedation. Participants in the lithium group tended to experience more tremor. Similar proportions of participants in the lithium and divalproex groups achieved target concentrations (57% and 56%, respectively). A longitudinal mixed model of improvement (change from baseline in YMRS score) favored lithium (change in score, 3.90; 97.5% CI=1.71, 6.09). Nine-week response rates did not differ significantly between the lithium and divalproex groups (79% and 73%, respectively). The need for adjunctive risperidone was low and similar between groups (17% and 14%, respectively).

Conclusions:

Both lithium and divalproex were adequately tolerated and efficacious; lithium was associated with a greater reduction in mania scores over 9 weeks.



中文翻译:

GERI-BD:锂盐和双丙戊酸钠治疗老年双相情感障碍患者躁狂症的随机双盲对照试验

客观的:

使用情绪稳定剂治疗老年双相情感障碍患者的临床医生需要来自特定年龄随机对照试验的证据。作者描述了第一个针对晚年躁狂症的此类研究的结果。

方法:

作者比较了 224 名 60 岁或以上患有躁狂、轻躁狂或混合发作的 I 型双相情感障碍住院患者和门诊患者对碳酸锂和双丙戊酸钠的耐受性和疗效。在双盲条件下,参与者被随机分配接受锂(目标血清浓度,0.80-0.99 mEq/L)或双丙戊酸钠(目标血清丙戊酸盐浓度,80-99 μg/mL)治疗,为期 9 周。三周后反应不充分的参与者接受了开放辅助利培酮治疗。作者假设双丙戊酸比锂具有更好的耐受性和更有效。根据镇静措施和达到目标浓度的参与者比例评估耐受性。使用年轻躁狂评定量表(YMRS)评估功效。

结果:

锂和双丙戊酸钠的流失率相似(第 3 周分别为 14% 和 18%,第 9 周分别为 51% 和 44%)。各组在镇静方面没有显着差异。锂盐组的参与者往往会经历更多的震颤。锂剂组和双丙戊酸钠组中达到目标浓度的参与者比例相似(分别为 57% 和 56%)。纵向混合改善模型(YMRS 评分相对于基线的变化)有利于锂(评分变化,3.90;97.5% CI=1.71, 6.09)。锂剂组和双丙戊酸钠组的九周缓解率没有显着差异(分别为 79% 和 73%)。两组之间对辅助利培酮的需求较低且相似(分别为 17% 和 14%)。

结论:

锂盐和双丙戊酸钠均具有足够的耐受性且有效;锂与 9 周内躁狂评分的大幅降低有关。

更新日期:2017-09-05
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