BACKGROUND: 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. METHODS: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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: 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. METHODS: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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Arthur N Westover; T Michael Kashner; Theresa M Winhusen; Richard M Golden; Paul A Nakonezny; Bryon Adinoff; Steven S Henley Journal: Am J Drug Alcohol Abuse Date: 2015-06-11 Impact factor: 3.829
Authors: Lin Li; Zheng Chang; Jiangwei Sun; Andreas Jangmo; Le Zhang; Lars Magnus Andersson; Tamara Werner-Kiechle; Ewa Ahnemark; Brian M D'Onofrio; Henrik Larsson Journal: JAMA Netw Open Date: 2022-04-01