Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression
Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression
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DOI：
10.1176/appi.ajp.161.3.564
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发表时间：
2004-03-01
影响因子：
17.7
通讯作者：
Endick, CJ
中科院分区：
文献类型：
--
作者：
Goldberg, JF;Burdick, KE;Endick, CJ
目的：以往的研究表明，多巴胺激动剂普拉克索可能具有抗抑郁作用。作者进行了一项初步的随机、安慰剂对照试验，以确定普拉克索治疗难治性双相情感障碍的安全性和抗抑郁疗效。方法：22名患有DSM-IV非精神病性双相情感障碍的抑郁症门诊患者被随机分配到安慰剂或灵活剂量的普拉克索(平均最大剂量为1.7 mg/d，SD 13)，在现有情绪稳定剂的基础上治疗6周。结果：服用普拉克索的患者(10例[83%])比服用安慰剂的患者(6例[60%])完成了研究。服用普拉克索的12名患者中有8名(67%)，服用安慰剂的10名患者中有2名(20%)汉密尔顿抑郁量表得分至少改善了50%。服用普拉克索的患者较基线汉密尔顿抑郁量表评分改善的平均百分比(48%)高于服用安慰剂的患者(21%)。与安慰剂相比，普拉克索对CGI严重程度的平均改善作用也更大。除1例患者在服用普拉克索时出现躁狂症状外，其余患者均未因不良反应而终止研究。结论：普拉克索是一种安全有效的双相抑郁患者的抗抑郁药物。需要更大规模的随机对照试验来确认这些初步观察结果。
Objective: Previous studies suggest that the dopamine agonist pramipexole may possess antidepressant properties. The authors conducted a preliminary randomized, placebo-controlled trial to determine the safety and antidepressant efficacy of pramipexole in treatment-resistant bipolar depression.Method: Twenty-two depressed outpatients with DSM-IV non-psychotic bipolar disorder were randomly assigned to receive placebo or flexibly dosed pramipexole (mean maximum dose= 1.7 mg/day, SD 13) added to existing mood stabilizers for 6 weeks. The primary outcome measure was response, defined as improvement in Hamilton Depression Rating Scale score of 50% or more over the baseline score; secondary analyses involved changes in Clinical Global Impression (CGI) severity scores.Results: More patients given pramipexole (10 [83%] of 12) than patients given placebo (six [60%] of 10) completed the study. Eight (67%) of 12 patients taking pramipexole and two (20%) of 10 taking placebo had an improvement of at least 50% in their Hamilton depression scale scores. The mean percentage of improvement from baseline Hamilton depression scale scores was greater for patients taking pramipexole (48%) than for those taking placebo (21%). Mean improvements in CGI severity were also greater with pramipexole than placebo. No patients discontinued the study because of adverse events except for one patient who became hypomanic while taking pramipexole.Conclusions: Pramipexole was a safe and effective antidepressant among patients with bipolar depression. Larger randomized, controlled trials are needed to affirm these initial observations.