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).
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.
Study Type
OBSERVATIONAL
Enrollment
289
Form = tablet, route = oral, administered as a flexible dosage
Form = tablet, route = oral;
Unnamed facility
Bucheon-Si Gyeonggi-Do, South Korea
Unnamed facility
Daegu, South Korea
Unnamed facility
Gyeongsangnam-Do, South Korea
Unnamed facility
Jeju Special Self-Governing Province, South Korea
Change from baseline in the ADHD Rating Scale (ARS)
The ADHD Rating Scale (ARS) - Parent Version: ARS contains 18 items, in which parent version of the questionnaire is based on home behaviors.
Time frame: Baseline and Week 52
Clinical Global Impression-Severity (CGI-S)
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.
Time frame: Baseline to Week 52
Adherence Rate
Pill count at each visit; at least 50% adherence rate will be considered clinically relevant.
Time frame: Week 4 to Week 52
Comprehensive Attention Test (CAT)
CAT is a computerized test which includes attention task, sustained attention to response, flanker task, divided attention task, and spatial working memory task.
Time frame: Baseline, Week 24 and Week 52
Academic Performance Rating Scale (APRS)
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.
Time frame: Baseline, Week 24 and Week 52
Symptoms Checklist (SCL-90) for Parent Depression
Time frame: Baseline, Week 24 and Week 52
Clinical Global Impression- Improvement (CGI-I)
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Unnamed facility
Jeonju, South Korea
Unnamed facility
Kyunggi-Do, South Korea
Unnamed facility
Seongnam, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Suwon, South Korea
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.
Time frame: Baseline and Week 52