A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
The purpose of this observational study is to explore the efficacy of methylphenidate hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time version (K-SADS-PL).
Attention-deficit Hyperactivity Disorder
Drug: Methylphenidate hydrochloride
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors|
- Change from baseline in the ADHD Rating Scale (ARS) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Clinical Global Impression- Improvement (CGI-I) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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;
This is a 1-year open-label (all people involved know the identity of the assigned drug), multicenter, single arm, prospective, observational study to explore under natural setting the efficacy of drug treatment in children and adolescents diagnosed with ADHD by K-SADS-PL (K-SADS-PL is a tool used for ADHD diagnosis. Patient may be diagnosed with ADHD by using K-SADS-PL to check if he or she meets the criteria according to Diagnostic and Statistical Manual of Mental Disorders & edition (DSM-IV). After obtaining informed consent, investigator will prescribe stimulant or non-stimulant ADHD treatment medications (ie, Immediate release [IR]/extended release [ER]/osmotic release oral system (OROS) methylphenidate, atomoxetine). Efficacy and safety assessments will be performed at 4, 12, 24, 36, and 52 weeks after the first day of giving study drug. Progression of symptom improvement and adherence will be investigated and associated variables (ie, demographic, clinical, familial and treatment factors) will be analyzed.
Please refer to this study by its ClinicalTrials.gov identifier: 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|