NCT01985581

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

A Single-Center, Randomized, Double Blind, Placebo-Controlled, Crossover Evaluation of the Effect of GXR as Adjunctive Treatment With Stimulant on Executive Function and Quality of Life at Home and School in Children With ADHD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: JPM van Stralen Medicine Professional · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Although stimulant medications have been shown to have positive impact on executive function (EF) (Findling et al, 2009; Hale et al. 2011), little has been documented about the effect of INTUNIV extended release on EF in children. The manifestation of clinical symptoms related to impairment in EF often leads to the search for additional treatment options and in many cases to adjunct therapies to the traditional stimulant medication treatment regimen. Demonstrating that the addition of INTUNIV extended release to usual stimulant therapy is effective for symptom control as well as in improving EF may influence clinical treatment algorithms and the need for health care resources to effectively manage patients. Since EF deficits negatively impact academic achievement and behavior at school and because children spend a large number of daytime hours at school, the concordance of any reported improvement in the school and the home environment will be examined. Overall improvement in quality of life with the addition of INTUNIV extended release will also be evaluated.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Guanfacine extended release
DRUG	Placebo
DRUG	Stimulant therapy	patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-11-15
• Last updated: 2016-05-23
• Results posted: 2016-05-23

Locations

1 site across 1 country: Canada