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PATIENCE Individual Patient DATa Network Meta-AnalysIs of the Efficacy aNd aCceptability of ADHD mEdication
Proposal
12586
Title of Proposed Research
PATIENCE Individual Patient DATa Network Meta-AnalysIs of the Efficacy aNd aCceptability of ADHD mEdication
Lead Researcher
Professor Samuele Cortese
Affiliation
Professor of Child and Adolescent Psychiatry, University of Southampton, UK; Honorary Consultant in Child and Adolescent Psychiatry, Solent NHS Trust, UK
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
19 December 2025
Lay Summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is a highly prevalent neurodevelopmental disorder which has been estimated to affect 5-7% of children and 2.5% of adults worldwide. It is characterised by inattention and/or hyperactivity-impulsivity, that lead to impairment in the family, classrooms, workplaces and social settings and can prevent individuals from maintaining relationships and reaching their full potential. A number of pharmacologic and non-pharmacologic treatments are available. A network meta-analysis (NMA) of published and unpublished data provided the most comprehensive evidence on the relative efficacy, safety and tolerability of pharmacological treatments across the lifespan at the group level. NMA is a statistical method that uses data from multiple randomised controlled trials (RCTs) and aims to estimate the relative effects of all available treatments for a certain condition. Common applications of NMA use aggregate data and estimate average treatment effects, i.e., treatment effects at the group level. The analysis of aggregate data, although useful on its own, cannot estimate treatment effects for specific types of patients, i.e., it cannot account for important differences in characteristics of the patients that may significantly moderate treatment effects (e.g., previous exposure to medication, specific comorbidities and severity of symptoms). PATIENCE, an Individual Patient Data Network Meta-Analysis (IPD-NMA), has been designed to use data from individual participants recruited in RCTs of ADHD medications, to enable more detailed and flexible analyses to be performed than those based on aggregate data. This will provide evidence to inform future clinical guidelines, support personalised approaches in the treatment of ADHD, and identify areas for further research.
Study Data Provided
[{ "PostingID": 4810, "Title": "NOVARTIS-CRIT124DUS02", "Description": "A multicenter, double-blind, randomized, placebo-controlled, crossover study evaluating the efficacy and safety of methylphenidate hydrocholoride in female adolescents diagnosed with attention deficit/hyperactivity disorder" },{ "PostingID": 21185, "Title": "NOVARTIS-CRIT124E2301", "Description": "A multicenter, double-blind, randomized, placebo-controlled, parallel-group, study of the efficacy and safety of Focalin LA (dexmethylphenidate HCl extended-release capsules) at 5-30 mg/day administered once daily in pediatric patients 6-17
years of age with Attention-Deficit/Hyperactivity Disorder" },{ "PostingID": 21186, "Title": "NOVARTIS-CRIT124D2302", "Description": "A 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset of attention deficit hyperactivity disorder (ADHD)" },{ "PostingID": 21187, "Title": "NOVARTIS-CRIT124E2302", "Description": "A 5-week, multicenter, double-blind, randomized, placebocontrolled,parallel-group, fixed-dose study of the efficacyand safety of Focalin™ LA (dexmethylphenidate hydrochloride extended-release capsules) administered once daily in adults with Attention-Deficit/Hyperactivity Disorder" }]
Statistical Analysis Plan
Publication Citation
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