Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
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
Outcome
Met primary endpoint
registry p = 0.0392; LS mean difference -3.0 (95% CI -5.9 to -0.2); ANOVA NCT01985581 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guanfacine | Small molecule | 1 mg | — |
| Subject | Guanfacine | Small molecule | 4 mg | — |
| Background | Adderall | Unknown | — | — |
| Background | Biphentin | Unknown | — | — |
| Background | Dextroamphetamine | Small molecule | — | — |
| Background | Lisdexamfetamine Dimesylate | Small molecule | — | — |
| Background | Methylphenidate | Small molecule | — | — |
| Background | Ritalin SR | Unknown | — | — |