Double-blind, placebo-controlled, crossover study of osmotic release oral system methylphenidate in adults with ADHD with assessment of oppositional and emotional dimensions of the disorder

Double-blind, placebo-controlled, crossover study of osmotic release oral system methylphenidate in adults with ADHD with assessment of oppositional and emotional dimensions of the disorder
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DOI:
10.4088/jcp.v68n0113
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发表时间:
2007-01-01
影响因子:
5.3
通讯作者:
Marchant, Barrie K.
Marchant, Barrie K.
中科院分区:
医学2区
文献类型:
--
作者:
Reimherr, Frederick W.;Williams, Erika D.;Marchant, Barrie K.

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背景资料:注意力缺陷/多动障碍(ADHD)往往会持续到成年,这一认识导致成年人的诊断和治疗频率增加。渗透释放口服系统(OROS)哌甲酯是一种长效兴奋剂被证明是有效的治疗儿童和青少年与ADHD.Method:47名成年人进入和41完成了这个双盲,安慰剂对照,交叉试验OROS哌甲酯。每个双盲组持续4周;数据收集时间为2004年8月至2005年12月。受试者符合DSM-IV-TR和犹他州成人ADHD标准。结果测量包括Wender-Reimherr成人注意力缺陷障碍量表(WRAADDS),成人ADHD评定量表(ADHD-RS)和临床总体印象改善量表(CGI-I)。在基线时,受试者被归类为具有WRAADDS的显著情绪症状和/或显著对立违抗症状,使用自我报告量表评估DSM-IV对立违抗障碍标准。17%的样本(N=8)仅患有ADHD,38%(N=18)患有ADHD+显著的情绪症状,40%(N=19)的ADHD患者同时伴有明显的情绪和对立症状。在平均+/- SD剂量为64.0 +/- 23.3(0.75 mg/kg)时,OROS哌甲酯在所有临床指标上均上级安慰剂:总WRAADDS评分分别降低42%和13%,p
Background: The realization that attention-deficit/hyperactivity disorder (ADHD) often persists into adulthood has led to increased frequency of diagnosis and treatment in adults. Osmotic release oral system (OROS) methylphenidate is a long-acting stimulant demonstrated to be effective in the treatment of children and adolescents with ADHD.Method: Forty-seven adults entered and 41 completed this double-blind, placebo-controlled, crossover trial of OROS methylphenidate. Each double-blind arm lasted 4 weeks; data were collected from August 2004 through December 2005. Subjects met both DSM-IV-TR and Utah Criteria for ADHD in adults. Outcome measures included the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), the adult ADHD-Rating Scale (ADHD-RS), and the Clinical Global Impressions-Improvement scale (CGI-I). At baseline, subjects were categorized as having significant emotional symptoms with the WRAADDS and/or significant oppositional-defiant symptoms using a self-report scale assessing the DSM-IV criteria for oppositional defiant disorder.Results: 17% of the sample (N=8) had ADHD alone, 38% (N=18) had ADHD plus significant emotional symptoms, and 40% (N=19) had ADHD with both significant emotional and oppositional symptoms. At a mean +/- SD dose of 64.0 +/- 23.3 (0.75 mg/kg), OROS methylphenidate proved superior to placebo for all clinical measures: total WRAADDS score decrease of 42% versus 13%, respectively, p