A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
|ClinicalTrials.gov Identifier: NCT01624649|
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : June 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Attention-deficit Hyperactivity Disorder||Drug: Methylphenidate hydrochloride Drug: Atomoxetine||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||289 participants|
|Official Title:||Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors|
|Study Start Date :||February 2012|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
Patients with ADHD
Patients will receive methylphenidate hydrochloride or atomoxetine. The methylphenidate hydrochloride is available in three forms. 1) Immediate release 2) Extended release 3) Osmotic release oral system
Drug: Methylphenidate hydrochloride
Form = tablet, route = oral, administered as a flexible dosageDrug: Atomoxetine
Form = tablet, route = oral;
- Change from baseline in the ADHD Rating Scale (ARS) [ Time Frame: Baseline and Week 52 ]The ADHD Rating Scale (ARS) - Parent Version: ARS contains 18 items, in which parent version of the questionnaire is based on home behaviors.
- Clinical Global Impression-Severity (CGI-S) [ Time Frame: Baseline to Week 52 ]CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Ratings are 1 = normal/not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = extremely ill.
- Adherence Rate [ Time Frame: Week 4 to Week 52 ]Pill count at each visit; at least 50% adherence rate will be considered clinically relevant.
- Comprehensive Attention Test (CAT) [ Time Frame: Baseline, Week 24 and Week 52 ]CAT is a computerized test which includes attention task, sustained attention to response, flanker task, divided attention task, and spatial working memory task.
- Academic Performance Rating Scale (APRS) [ Time Frame: Baseline, Week 24 and Week 52 ]APRS is a 19-item scale, where parents rate the child's academic abilities and behaviors on a 5-point scale. Higher scores indicate greater academic performance.
- Symptoms Checklist (SCL-90) for Parent Depression [ Time Frame: Baseline, Week 24 and Week 52 ]
- Clinical Global Impression- Improvement (CGI-I) [ Time Frame: Baseline and Week 52 ]CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as 1, every much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624649
|Korea, Republic of|
|Bucheon-Si Gyeonggi-Do, Korea, Republic of|
|Dae-Gu, Korea, Republic of|
|Gyeongsangnam-Do, Korea, Republic of|
|Jeju Special Self-Governing Province, Korea, Republic of|
|Jeonju-Si, Korea, Republic of|
|Kyunggi-Do, Korea, Republic of|
|Seongnam, Korea, Republic of|
|Seoul, Korea, Republic of|
|Suwon, Korea, Republic of|
|Principal Investigator:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|