A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors

Conditions
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Attention-deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Methylphenidate hydrochloride
* Drug: Atomoxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ADHD<br>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<br>* Form = tablet, route = oral, administered as a flexible dosage<br>Drug: Atomoxetine<br>* Form = tablet, route = oral;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention-deficit hyperactivity disorder, Developmental disorder, Atomoxetine, Methylphenidate, Psychiatric disorder