Eur Arch Psychiatry Clin Neurosci. 1997;247(2):71-80.
The primary objectives of this large multicenter study (n = 578) were to determine the efficacy and safety of moclobemide, 300 or 600 mg per day, for the treatment of social phobia. A double-blind fixed-dose parallel group study was conducted to compare the two different doses of moclobemide to placebo. After a 1-week placebo run-in period, patients were randomly assigned to one of the three treatment groups to receive the test compound for a 12-week period. Assessments were performed at screen, on baseline and on weeks 1, 2, 3, 4, 6, 8, 10, and 12. There were consistent, reliable and clinically meaningful drug effects and indications of a dose-response relationship. Statistical analysis of the results at both weeks 8 and 12 showed that 600 mg of moclobemide was effective and statistically significantly superior to placebo. The 300 mg dose also showed better efficacy than placebo on all measures of efficacy, and about half of them were statistically significantly different from placebo. Moclobemide was well tolerated. Adverse events, except for insomnia, were neither dose-related nor were there significant drug-placebo differences. The results indicate that 600 mg of moclobemide per day given b.i.d. is effective in social phobia, reducing the symptoms and the impairment associated with the disorder. The compound is well tolerated and safe.
这项大型多中心研究(n = 578)的主要目的是确定每天300毫克或600毫克吗氯贝胺治疗社交恐惧症的疗效和安全性。进行了一项双盲固定剂量平行组研究,以比较两种不同剂量的吗氯贝胺与安慰剂。在为期1周的安慰剂导入期后,患者被随机分配到三个治疗组之一,接受试验化合物治疗12周。在筛选时、基线时以及第1、2、3、4、6、8、10和12周进行评估。存在一致、可靠且具有临床意义的药物效应以及剂量反应关系的迹象。第8周和第12周结果的统计分析表明,600毫克吗氯贝胺有效且在统计学上显著优于安慰剂。300毫克剂量在所有疗效指标上也显示出比安慰剂更好的疗效,其中约一半在统计学上与安慰剂有显著差异。吗氯贝胺耐受性良好。除失眠外,不良事件与剂量无关,药物与安慰剂之间也无显著差异。结果表明,每天两次给予600毫克吗氯贝胺对社交恐惧症有效,可减轻与该疾病相关的症状和损害。该化合物耐受性良好且安全。