N/A
N=83
Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01912352 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks — 14.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Methylphenidate (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Seoul National University
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks |
14.9 | — |
| SECONDARY Clinical Global Impression-Improvement Scale at 8 Weeks |
2.3 | — |
Summary
The aims of the current study are to examine gene-environment interactions associated with norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic changes in norepinephrine pathway are associated with differences in functional connectivity of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore, this study aims to examine neurobiological markers, such as intermediate neuroimaging phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD. Through evaluating drug responses and side effects with the associated measures of clinical, neuropsychological and neuroimaging characteristics, investigators would like to investigate predictors of treatment response associated with NE system genes in ADHD.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Attention-deficit Hyperactivity Disorder
- 6-18 years old
Exclusion Criteria
- History of neurological diseases, including convulsive disorders or brain damage
- IQ below 70
- Pervasive developmental disorder (autism)
- Language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).
- Tourette's syndrome
- Bipolar disorder
- Psychosis
Data sourced from ClinicalTrials.gov (NCT01912352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.