Attention-deficit Hyperactivity Disorder
Conditions
Keywords
Attention-deficit hyperactivity disorder, Developmental disorder, Atomoxetine, Methylphenidate, Psychiatric disorder
Brief summary
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).
Detailed description
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.
Interventions
DRUGMethylphenidate hydrochloride
Form = tablet, route = oral, administered as a flexible dosage
DRUGAtomoxetine
Form = tablet, route = oral;
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Has been diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-SADS-present and life time version (K-SADS-PL) * Have not received methylphenidate or atomoxetine within 3 months prior to screening.
Exclusion criteria
* Has intelligence quotient (IQ) ≤70 assessed by comprehensive attention test (CAT) at screening diagnosed with congenital disorders * Has had history of acquired brain damage (eg, cerebral palsy) * Has had diagnosed with convulsive disabilities or other neurological disease or dysesthesia * Has had developmental disabilities such as autistic spectrum disorder * Has had history of schizophrenia, bipolar, or other pediatric psychotic disorder, and obsessive compulsive disorder * Has had linguistic disability and had diagnosed with tic disorder that requires additional drug treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the ADHD Rating Scale (ARS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Severity (CGI-S) | 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 | Week 4 to Week 52 | Pill count at each visit; at least 50% adherence rate will be considered clinically relevant. |
| Clinical Global Impression- Improvement (CGI-I) | 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. |
| Academic Performance Rating Scale (APRS) | 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 | Baseline, Week 24 and Week 52 | — |
| Comprehensive Attention Test (CAT) | 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. |
Countries
South Korea
Outcome results
None listed