drugset / Trial / NCT02259517

An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD

NCT02259517 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two types of medications with differing mechanisms of action: stimulants and non-stimulants. The stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that both medications are effective in reducing ADHD symptoms, although the neurobiological mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of this study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients with ADHD. MRI scanning will be used to identify treatment-related changes in brain structure and function.

Timeline

Start
2014-09
Primary completion
2021-11-06
Completion
2021-11-06

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment/enrollment ended early due to the COVID-19 pandemic”

Drugs

EvaluationDrugModalityDoseRoute
Subject Guanfacine Small molecule 1 mg —
Subject Guanfacine Small molecule 4 mg —
Subject Lisdexamfetamine Other / unclassified 30 mg —
Subject Lisdexamfetamine Other / unclassified 70 mg —