Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder
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|ClinicalTrials.gov Identifier: NCT01912352|
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Methylphenidate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Gene-environment Interactions and Brain Functional Connectivity Associated With Norepinephrine System Genes in Attention Deficit Hyperactivity Disorder|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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.
- Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks [ Time Frame: 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.
- Clinical Global Impression-Improvement Scale at 8 Weeks [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912352
|Principal Investigator:||Jae-Won Kim, MD., PhD.||Seoul National University and Seoul National University Hospital|