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| ID | Type | Description | Link |
|---|---|---|---|
| CONCERTAATT4107 | Other Identifier | Janssen Korea, Ltd., Korea | |
| CON-KOR-5026 | Other Identifier | Janssen Korea, Ltd., Korea |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate hydrochloride | Drug | Form = tablet, route = oral, administered as a flexible dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon-Si Gyeonggi-Do | South Korea | |||||
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| Atomoxetine | Drug | Form = tablet, route = oral; |
|
| Baseline to Week 52 |
| Adherence Rate | Pill count at each visit; at least 50% adherence rate will be considered clinically relevant. | 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. | 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. | Baseline, Week 24 and Week 52 |
| Symptoms Checklist (SCL-90) for Parent Depression | 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. | Baseline and Week 52 |
| Daegu |
| South Korea |
| Gyeongsangnam-Do | South Korea |
| Jeju Special Self-Governing Province | South Korea |
| Jeonju | South Korea |
| Kyunggi-Do | South Korea |
| Seongnam | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D002658 | Developmental Disabilities |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
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