Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, ADRA2A, Methylphenidate, Response
Brief 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.
Interventions
DRUGMethylphenidate
Sponsors
Korea Research Foundation
Seoul National University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks | baseline and 8 weeks | Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms). Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Improvement Scale at 8 Weeks | baseline and 8 weeks | Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: Compared to the patient's condition at baseline \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Clinical Global Impression-Improvement was measured at 8 weeks. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methylphenidate Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment. | 83 |
| Total | 83 |
Baseline characteristics
| Characteristic | Methylphenidate |
|---|---|
| Age, Continuous | 9.5 years STANDARD_DEVIATION 2.6 |
| Region of Enrollment Korea, Republic of | 83 participants |
| Scores on the ADHD Rating Scale-IV | 26.1 units on a scale STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 83 |
| serious Total, serious adverse events | 0 / 83 |
Outcome results
Primary
Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks
Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms). Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks.
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylphenidate | Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks | 14.9 units on a scale | Standard Deviation 10.9 |
Secondary
Clinical Global Impression-Improvement Scale at 8 Weeks
Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: Compared to the patient's condition at baseline \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Clinical Global Impression-Improvement was measured at 8 weeks.
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylphenidate | Clinical Global Impression-Improvement Scale at 8 Weeks | 2.3 units on a scale | Standard Deviation 0.7 |