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

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

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).

Study Overview

• Status: Completed
• Conditions: Attention-deficit Hyperactivity Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 289

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon-Si Gyeonggi-Do, Korea, Republic of
  • Dae-Gu, Korea, Republic of
  • Gyeongsangnam-Do, Korea, Republic of
  • Jeju Special Self-Governing Province, Korea, Republic of
  • Jeonju-Si, Korea, Republic of
  • Kyunggi-Do, Korea, Republic of
  • Seongnam, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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;

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea
• Investigators: Principal Investigator: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Methylphenidate; Psychiatric disorder; Atomoxetine; Attention-deficit hyperactivity disorder; Developmental disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Adrenergic Uptake Inhibitors; Methylphenidate; Atomoxetine Hydrochloride
• Other Study ID Numbers: CR100744; CONCERTAATT4107 (Other Identifier: Janssen Korea, Ltd., Korea); CON-KOR-5026 (Other Identifier: Janssen Korea, Ltd., Korea)