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首页> 外文期刊>The journal of clinical psychiatry >An 8-week, randomized controlled trial of atomoxetine, atomoxetine plus buspirone, or placebo in adults with ADHD
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An 8-week, randomized controlled trial of atomoxetine, atomoxetine plus buspirone, or placebo in adults with ADHD

机译：一项为期8周的阿莫西汀，阿莫西汀加丁螺环酮或安慰剂在ADHD成人中的随机对照试验

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Objective: To examine the efficacy and safety of atomoxetine combined with buspirone versus atomoxetine monotherapy and placebo in adult attention-deficit/hyperactivity disorder (ADHD). Method: In this randomized, 8-week, 3-arm, double-blind, placebo-controlled trial conducted from November 2004 through December 2005, 241 adults with ADHD were randomly assigned in a 2:2:1 ratio to receive up to twice-daily atomoxetine and thrice-daily buspirone (n = 97), twice-daily atomoxetine (n = 97), or placebo (n = 47). Participants met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for ADHD. The primary efficacy measure was the adult ADHD Investigator Symptom Rating Scale (AISRS). Results: Decrease in the AISRS total score was significantly greater for atomoxetine-buspirone than placebo at all time points from weeks 1 to 7, with an estimated mean difference of -4.80 (P = .001). Reduction in the mean AISRS total score was numerically greater for atomoxetine-buspirone than for atomoxetine at all time points, but statistically significant at week 4 only (estimated difference = -2.04, P < .10). The effect size for atomoxetine plus buspirone was 0.51, and for atomoxetine alone, it was 0.40. Insomnia, nausea, dry mouth, headache, and asthenia were frequently reported adverse events for both active treatment groups, and dizziness was also frequently reported for the atomoxetine-buspirone group. Discontinuations due to treatment-related adverse effects were 15.5% for atomoxetine-buspirone, 11.3% for atomoxetine, and 14.9% for placebo. Conclusions: There was little indication of improvement for atomoxetine plus buspirone versus atomoxetine monotherapy, as most efficacy measures showed only slightly greater quantitative improvement for the combination, generally without statistical significance. It is of note, however, that the quantitative differences between these 2 groups were virtually all in the direction of greater efficacy for the atomoxetine plus buspirone group. Trial Registration: clinicaltrials.gov Identifier: NCT00174226.
机译：目的：探讨阿莫西汀联合丁螺环酮与阿莫西汀单药联合安慰剂治疗成人注意力不足/多动症（ADHD）的有效性和安全性。方法：在这项2004年11月至2005年12月进行的随机，为期8周，三臂，双盲，安慰剂对照的试验中，以2：2：1的比例随机分配了241名ADHD成人，最多接受两次每日一次阿托西汀和三次丁螺环酮（n = 97），每日两次阿托西汀（n = 97）或安慰剂（n = 47）。参加者符合《精神疾病诊断和统计手册》第四版，关于多动症的文本修订标准。主要疗效指标是成人多动症调查者症状评定量表（AISRS）。结果：从第1周到第7周的所有时间点，阿托西汀-丁螺环酮的AISRS总评分降低幅度明显大于安慰剂，估计平均差异为-4.80（P = .001）。在所有时间点，阿莫西汀-丁螺环酮的平均AISRS总得分降低幅度均大于阿莫西汀，但仅在第4周时具有统计学意义（估计差异= -2.04，P <.10）。阿莫西汀加丁螺环酮的有效量为0.51，单用阿托西汀的有效量为0.40。两个活跃的治疗组都经常报告失眠，恶心，口干，头痛和虚弱，阿托西汀-丁螺环酮组也经常出现头晕。因治疗相关不良反应而停药的结果为：阿莫西汀-丁螺环酮为15.5％，阿莫西汀为11.3％，安慰剂为14.9％。结论：阿莫西汀加丁螺环酮与阿莫西汀单药治疗相比，几乎没有改善的迹象，因为大多数疗效指标显示该组合的定量改善仅稍大，通常无统计学意义。然而，值得注意的是，这两组之间的定量差异实际上都是朝着阿莫西汀加丁螺环酮组更高疗效的方向。试验注册：clinicaltrials.gov标识符：NCT00174226。

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