Journal article

Functional impairment outcomes in clinical trials of different ADHD medications: post hoc responder analyses and baseline subgroup analyses

David R Coghill, Tamara Werner-Kiechle, Sepehr Farahbakhshian, Caleb Bliss, Brigitte Robertson, Michael Huss

European Child and Adolescent Psychiatry: official journal of the European Society for Child and Adolescent Psychiatry | SPRINGER | Published : 2020


Several recent phase 3 clinical trials of attention-deficit/hyperactivity disorder (ADHD) medications have used the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P). Here, we assess WFIRS-P response in individual patients in two pivotal trials of lisdexamfetamine dimesylate (LDX) and guanfacine extended release (GXR). We also analysed pooled WFIRS-P data from seven phase 3 studies of ADHD medications to shed light on factors associated with baseline functional impairment. The proportion of patients with a change in WFIRS-P score that exceeded the minimal important difference (MID) criteria for response was greater for LDX than placebo in the Family, Learning and School, and R..

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Funding Acknowledgements

We thank the participants and investigators involved in the studies. This post hoc analysis and the original studies were funded by the sponsor, Shire Development LLC, a member of the Takeda group of companies. Under the direction of the authors and funded by Shire International GmbH, a member of the Takeda group of companies, Dr MG Cottingham and Dr AL Jones of Oxford PharmaGenesis provided writing assistance for this publication. Editorial assistance in formatting, proofreading, copy editing and fact checking was also provided by Oxford PharmaGenesis. Although employees of the sponsor were involved in the study design, data collection, analysis and interpretation, and fact checking of information, the content of this manuscript, the interpretation of the data and the decision to submit the manuscript for publication in European Child and Adolescent Psychiatry was made by the authors independently. Dr C Bliss served as the statistical expert for this research.