drugset / Trial / NCT01985581

Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD

NCT01985581

Phase 4 Completed 50 enrolled JPM van Stralen Medicine Professional
RandomizedCrossoverQuadruple-blindTreatment

Summary

This study looks to examine whether or not INTUNIV extended release can help children aged 6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving Executive Function when added to their usual care stimulant therapy. Executive functions are a set of mental processes that include emotional control, planning, organization, working memory, inhibition of behaviors, and managing time and space. As children with ADHD usually have difficulties with Executive Function, and Executive function difficulties lead to more difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release to usual stimulant therapy will improve Executive Function scores as rated by parents and teachers. Improvements in quality of life will also be measured.

Timeline

Start
2013-10
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Guanfacine Small molecule 1 mg
Subject Guanfacine Small molecule 4 mg
Background Dextroamphetamine Small molecule
Background Lisdexamfetamine Dimesylate Small molecule
Background Methylphenidate Small molecule