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| Name | Class |
|---|---|
| Korea Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Experimental | Participants were treated with methylphenidate (ranging from to 63mg) for 8 weeks. Doses of methylphenidate were titrated depending on symptoms and adverse eff ects at the 2nd and 4th weeks of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Won Kim, MD., PhD. | Seoul National University and Seoul National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29905488 | Derived | Kim JI, Kim JW, Shin I, Kim BN. Effects of Interaction Between DRD4 Methylation and Prenatal Maternal Stress on Methylphenidate-Induced Changes in Continuous Performance Test Performance in Youth with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2018 Oct;28(8):562-570. doi: 10.1089/cap.2018.0054. Epub 2018 Jun 15. | |
| 25964505 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jae-Won Kim | Seoul National University | 822-2072-3648 | adore412@paran.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| baseline and 8 weeks |
| Kim JW, Sharma V, Ryan ND. Predicting Methylphenidate Response in ADHD Using Machine Learning Approaches. Int J Neuropsychopharmacol. 2015 May 10;18(11):pyv052. doi: 10.1093/ijnp/pyv052. |
| 25201318 | Derived | Hong SB, Zalesky A, Park S, Yang YH, Park MH, Kim B, Song IC, Sohn CH, Shin MS, Kim BN, Cho SC, Kim JW. COMT genotype affects brain white matter pathways in attention-deficit/hyperactivity disorder. Hum Brain Mapp. 2015 Jan;36(1):367-77. doi: 10.1002/hbm.22634. Epub 2014 Sep 9. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Scores on the ADHD Rating Scale-IV | Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms). | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 8 weeks |
|
|
|
| 0 |
| 83 |
| 47 |
| 83 |
| decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tiredness | Nervous system disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Trouble sleeping | Psychiatric disorders | Non-systematic Assessment |
|
| Nail biting | Psychiatric disorders | Non-systematic Assessment |
|
| Proness to crying | Psychiatric disorders | Non-systematic Assessment |
|
| Tic | Psychiatric disorders | Non-systematic Assessment |
|
| Depressive mood | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Excitability | Psychiatric disorders | Non-systematic Assessment |
|
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |