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首页> 外文期刊>Journal of clinical psychopharmacology >Augmentation of clozapine with ziprasidone in refractory schizophrenia: A double-blind, placebo-controlled study
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Augmentation of clozapine with ziprasidone in refractory schizophrenia: A double-blind, placebo-controlled study

机译：齐拉西酮增强氯氮平治疗难治性精神分裂症的双盲，安慰剂对照研究

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The present 16-week double-blind, randomized, placebo-controlled trial was aimed to explore the efficacy of ziprasidone add-on pharmacotherapy on clinical symptoms and cognitive functioning in 40 schizophrenic patients (active group, n = 20; placebo group, n = 20) with residual symptoms (Brief Psychiatric Rating Scale mean [SD] baseline total score in active group vs placebo, 40.4 [5.9] vs 37.9 [6.8]) despite receiving clozapine monotherapy at the highest tolerated dosage. The results obtained evidenced that ziprasidone augmentation of clozapine significantly reduced Positive and Negative Syndrome Scale "Negative" (P = 0.006, mean change [SD] in active group vs placebo, -2.7 [2.3] vs 1.1 [2.1], Cohen d = 1.7) and "General Psychopathology" (P = 0.009, mean change [SD] in active group vs placebo, -5.3 [3.8] vs -0.7 [2.0], Cohen d = 1.5). Regarding cognitive domains, ziprasidone was more effective than placebo in improving semantic fluency (P < 0.0001, mean change [SD] in active group vs placebo, 4.4 [3.5] vs -0.1 [4.1], Cohen d = 1.2). Ziprasidone had only a small effect on prolongation of heart-rate corrected QT interval (QTc) of the electrocardiogram, not significantly different from placebo (QTc milliseconds, mean [SD], week 16 in active group vs placebo, 408.17 [20.85] vs 405.45 [17.11], P = 0.321); within-group comparison revealed that QTc prolongation induced by ziprasidone was statistically significant (baseline vs week 16, P = 0.002).Ziprasidone added to clozapine was effective on negative and cognitive symptoms, although it may be proposed as a helpful treatment in schizophrenia, mainly for those patients who partially respond to clozapine monotherapy.
机译：本项为期16周的双盲，随机，安慰剂对照试验旨在探讨ziprasidone附加药物治疗对40例精神分裂症患者的临床症状和认知功能的影响（活动组，n = 20;安慰剂组，n = 20）尽管接受了最高耐受剂量的氯氮平单药治疗，但仍有残余症状（活动组与安慰剂组的简明精神病学评分量表平均[SD]基线总分，40.4 [5.9]对37.9 [6.8]）。获得的结果表明，齐拉西酮对氯氮平的增加显着降低了阳性和阴性综合征量表的“阴性”（P = 0.006，活动组与安慰剂的平均变化[SD]，-2.7 [2.3] vs 1.1 [2.1]，Cohen d = 1.7 ）和“一般精神病理学”（P = 0.009，活动组与安慰剂的平均变化[SD]，-5.3 [3.8]与-0.7 [2.0]，Cohen d = 1.5）。关于认知域，齐拉西酮在改善语义流畅性方面比安慰剂更有效（P <0.0001，活动组与安慰剂的平均变化[SD]，4.4 [3.5] vs -0.1 [4.1]，Cohen d = 1.2）。 Ziprasidone对延长心电图的心率校正QT间隔（QTc）的影响很小，与安慰剂组（QTc毫秒，平均值[SD]，活跃组vs安慰剂组，第16周）408.17 [20.85] vs 405.45无显着差异。 [17.11]，P = 0.321）;组内比较显示，齐拉西酮诱导的QTc延长具有统计学意义（基线vs第16周，P = 0.002）。氯氮平中加入齐拉西酮对阴性和认知症状有效，尽管它可能被建议作为治疗精神分裂症的有用方法，主要是适用于部分对氯氮平单一疗法有反应的患者。

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