drugset / Trial / NCT03333668

Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents

NCT03333668

RandomizedCrossoverDouble-blindBasic science

Summary

This is not a clinical trial. The aim of this study is to understand the mechanism of action of two recently licensed drugs for ADHD on brain function. We will compare the brain activation changes elicited by Guanfacine extended release (GXR; a non-stimulant drug) with the brain activation changes elicited by Lisdexamfetamine (LISDEX; a stimulant drug) and by placebo in 20 drug-free patients with ADHD using functional Magnetic Resonance Imaging (fMRI). For this purpose we intend to scan participants during their performance of tasks of attention, working memory, and inhibition, which we know from previous studies to elicit abnormal brain activation patterns in ADHD patients (Rubia et al., 2005; Smith et al., 2006).

Timeline

Start
2018-10-01
Primary completion
2022-12-31
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Guanfacine Small molecule 0.05 mg/kg Oral
Subject Lisdexamfetamine Other / unclassified 20 mg
Subject Lisdexamfetamine Other / unclassified 30 mg
Subject Lisdexamfetamine Other / unclassified 40 mg
Subject Lisdexamfetamine Other / unclassified 50 mg