Methylphenidate for Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) – unpublished or unregistered randomised clinical trials

Abstract

AbstractIntroductionThis is a follow-up study on our recent systematic review by Storebø and colleagues on methylphenidate for children and adolescents with attention-deficit/hyperactivity disorder (ADHD) published in The Cochrane Library. We aim to investigate the risks of research waste and publication bias in randomised clinical trials investigating methylphenidate versus placebo or no intervention for children and adolescents with ADHD.MethodThe method used includes our initial cohort of randomised clinical trials selected from searchingClinicaltrials.govand the EUCTR with the following criteria: methylphenidate versus placebo or no intervention with or without co-interventions for children or adolescents with ADHD, randomised clinical trials, any dosage, any delivery method, and at least 75% children and adolescents with ages less than 18 years as well as a time period of 1999-2022.Our primary objective is to assess how many randomised clinical trials of methylphenidate on children and adolescents with ADHD are registered in protocol databases, but never published in academic literature or as tabular summary results. The number of participants included in these trials is a secondary objective. Our third objective is to examine the relationship between trial results and the chance of being published. Our fourth objective is to assess the time from registry to publication of randomised clinical trials of methylphenidate on children and adolescents with ADHD in either a journal or as summary results, and the number of participants in these trials. The cutoff time for a publication to be considered timely published will be 6 months, as per European Medicines Agency guidelines for clinical trials involving children.ResultsThis is our protocol for the study and no results are presently available.