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

Sponsor

Janssen Korea, Ltd., Korea (Industry)

Overall Status

Completed

CT.gov ID

NCT01624649

Collaborator

(none)

289

Enrollment

Locations

Duration (Months)

32.1

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Attention-deficit Hyperactivity Disorder	Drug: Methylphenidate hydrochloride Drug: Atomoxetine

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.

Study Design

Study Type:

Observational

Actual Enrollment :

289 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Methylphenidate hydrochloride Form = tablet, route = oral, administered as a flexible dosage Drug: Atomoxetine Form = tablet, route = oral;

Arm

Intervention/Treatment

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

Drug: Methylphenidate hydrochloride

Form = tablet, route = oral, administered as a flexible dosage

Drug: Atomoxetine

Form = tablet, route = oral;

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	Country
1	Bucheon-Si Gyeonggi-Do	Korea, Republic of
2	Dae-Gu	Korea, Republic of
3	Gyeongsangnam-Do	Korea, Republic of
4	Jeju Special Self-Governing Province	Korea, Republic of
5	Jeonju-Si	Korea, Republic of
6	Kyunggi-Do	Korea, Republic of
7	Seongnam	Korea, Republic of
8	Seoul	Korea, Republic of
9	Suwon	Korea, Republic of