UMC St. Radboud, Department of Cognitive Neuroscience, Nijmegen, The Netherlands.
Prog Neuropsychopharmacol Biol Psychiatry. 2011 Mar 30;35(2):554-60. doi: 10.1016/j.pnpbp.2010.12.016. Epub 2010 Dec 23.
We conducted a post-hoc analysis of the Long-Acting MethylpheniDate in Adult attention-deficit hyperactivity disorder (LAMDA) study to investigate predictors of response in adults with ADHD randomly assigned to Osmotic Release Oral System (OROS)(®)-methylphenidate hydrochloride (MPH) 18, 36 or 72 mg or placebo.
LAMDA comprised a 5-week, double-blind (DB) period, followed by a 7-week, open-label (OL) period. A post-hoc analysis of covariance and a logistic regression analysis were undertaken to detect whether specific baseline parameters or overall treatment compliance during the double-blind phase contributed to response. The initial model included all covariates as independent variables; a backward stepwise selection method was used, with stay criteria of p<0.10. Six outcomes were considered: change from baseline CAARS:O-SV (physician-rated) and CAARS:S-S (self-report) scores at DB and OL end points, and response rate (≥30% decrease in CAARS:O-SV score from baseline) and normalization of CAARS:O-SV score at DB end point.
Taking into account a significant effect of OROS(®)-MPH treatment versus placebo in the original analysis (p≤0.015), across the outcomes considered in this post-hoc analysis, higher baseline CAARS scores were most strongly predictive of superior outcomes. Male gender and lower academic achievement were also predictive for improved results with certain outcomes.
Several baseline factors may help to predict better treatment outcomes in adults receiving OROS(®)-MPH; however, further research is required to confirm these findings and examine their neurobiological underpinnings.
我们对长效哌醋甲酯治疗成人注意缺陷多动障碍(LAMDA)研究进行了事后分析,以调查在 ADHD 成人患者中,使用渗透型控释口服溶液(OROS)®-盐酸哌甲酯(MPH)18mg、36mg 或 72mg 或安慰剂随机分组的患者,反应的预测因子。
LAMDA 包括 5 周的双盲(DB)期,随后是 7 周的开放标签(OL)期。采用协方差的事后分析和逻辑回归分析,以检测特定的基线参数或双盲期的整体治疗依从性是否有助于反应。初始模型包括所有协变量作为自变量;采用向后逐步选择方法,保留标准为 p<0.10。考虑了六个结果:从基线 CAARS:O-SV(医生评定)和 CAARS:S-S(自我报告)评分在 DB 和 OL 终点的变化,以及反应率(CAARS:O-SV 评分从基线下降≥30%)和 DB 终点时 CAARS:O-SV 评分的正常化。
考虑到 OROS(®)-MPH 治疗与安慰剂在原始分析中的显著效果(p≤0.015),在本事后分析中考虑的所有结果中,基线 CAARS 评分越高,结果越好。男性性别和较低的学业成绩也与某些结果的改善相关。
一些基线因素可能有助于预测接受 OROS(®)-MPH 治疗的成年人更好的治疗结果;然而,需要进一步的研究来证实这些发现并研究其神经生物学基础。