An observational study in Attention-deficit Hyperactivity Disorder, sponsored by Janssen Korea, Ltd., Korea. Completed at 9 sites in Korea, Republic of. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2015-06-09.
Sponsored by Janssen Korea, Ltd., Korea · Observational
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 289 is above the median of 134 across 122 observational studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children and adolescents of age between 6 and 15 years (in Korean age) who are dianosed with ADHD by K-SADS-PL but have never received any of methylphenidate or atomoxetine within 3 months prior to screening.
Exclusion Criteria:
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 · Drug: Atomoxetine
Form = tablet, route = oral, administered as a flexible dosage
Form = tablet, route = oral;
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)
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
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Janssen Korea, Ltd., Korea