Merck Sharp & Dohme Corp, Whitehouse Station, New Jersey, USA.
J Clin Psychiatry. 2012 Jul;73(7):e891-8. doi: 10.4088/JCP.11m07178.
It has been suggested that the histamine subtype 3 receptor inverse agonists such as MK-0249 might be effective in treating attention-deficit/hyperactivity disorder (ADHD). We evaluated the effects of MK-0249 in adults with ADHD.
A randomized, double-blind, placebo-controlled, incomplete block, 2-period crossover study of MK-0249 5-10 mg/d and osmotic-release oral system (OROS) methylphenidate 54-72 mg/d (active comparator) was performed in 72 men and women aged ≥ 18 to ≤ 55 years who met DSM-IV criteria for ADHD of either inattentive or combined subtype and who had a chronic course of behavior disorder. The study was conducted from August 2007 through April 2008 at 6 US sites. Primary efficacy was assessed by the mean change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score after 4 weeks of treatment.
Change from baseline in AISRS at week 4 for MK-0249 was not different from placebo (P = .341), whereas a significant benefit was seen for OROS methylphenidate versus placebo (P < .001). Analysis of secondary end points, including the Conners Adult ADHD Rating Scales, showed results consistent with the AISRS. A similar percentage of patients reported adverse events for MK-0249 compared with placebo (73% versus 69%, respectively). However, a greater percentage of patients reported insomnia as an adverse event with MK-0249 treatment compared with placebo (32% versus 11%, respectively).
MK-0249 10 mg/d is not effective for the treatment of adult ADHD.
ClinicalTrials.gov identifier: NCT00475735.
有人提出，组氨酸 3 型受体反向激动剂（如 MK-0249）可能对治疗注意缺陷多动障碍（ADHD）有效。我们评估了 MK-0249 在 ADHD 成人患者中的疗效。
一项多中心、双盲、安慰剂对照、不完全区组、2 周期交叉研究，纳入了 72 名年龄在 18 至 55 岁之间的男性和女性，这些患者符合 DSM-IV 注意力缺陷多动障碍诊断标准（伴或不伴注意缺陷型），具有慢性行为障碍，且正在接受治疗。患者接受 MK-0249 5-10 mg/d 和奥昔布宁控释片（OROS）哌甲酯 54-72 mg/d（阳性对照药）治疗，疗程为 4 周。该研究于 2007 年 8 月至 2008 年 4 月在美国 6 个地点进行。主要疗效终点是治疗 4 周后成人 ADHD 症状评定量表（AISRS）总分的变化。
与安慰剂相比，MK-0249 治疗 4 周后 AISRS 总分的变化无显著差异（P =.341），而 OROS 哌甲酯与安慰剂相比有显著改善（P <.001）。次要终点的分析，包括 Conners 成人 ADHD 评定量表，结果与 AISRS 一致。MK-0249 组与安慰剂组报告不良反应的患者比例相似（分别为 73%和 69%）。然而，MK-0249 治疗组报告失眠的患者比例高于安慰剂组（分别为 32%和 11%）。
MK-0249 10 mg/d 对成人 ADHD 无效。
ClinicalTrials.gov 标识符：NCT00475735。
