A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Attention-deficit Hyperactivity Disorder |
Drug: Methylphenidate hydrochloride Drug: Atomoxetine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors |
- Change from baseline in the ADHD Rating Scale (ARS) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The ADHD Rating Scale (ARS) - Parent Version: ARS contains 18 items, in which parent version of the questionnaire is based on home behaviors.
- Clinical Global Impression-Severity (CGI-S) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 4 to Week 52 ] [ Designated as safety issue: No ]Pill count at each visit; at least 50% adherence rate will be considered clinically relevant.
- Comprehensive Attention Test (CAT) [ Time Frame: Baseline, Week 24 and Week 52 ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline, Week 24 and Week 52 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, Week 24 and Week 52 ] [ Designated as safety issue: No ]
- Clinical Global Impression- Improvement (CGI-I) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 381 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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;
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
| Korea, Republic of | |
| Active, not recruiting | |
| Bucheon-Si Gyeonggi-Do, Korea, Republic of | |
| Active, not recruiting | |
| Dae-Gu, Korea, Republic of | |
| Active, not recruiting | |
| Gyeongsangnam-Do, Korea, Republic of | |
| Active, not recruiting | |
| Jeju Special Self-Governing Province, Korea, Republic of | |
| Active, not recruiting | |
| Jeonju-Si, Korea, Republic of | |
| Active, not recruiting | |
| Kyunggi-Do, Korea, Republic of | |
| Active, not recruiting | |
| Seognam-Si, Kyungki-Do, Korea, Republic of | |
| Active, not recruiting | |
| Seoul, Korea, Republic of | |
| Recruiting | |
| Suwon, Korea, Republic of | |
| Principal Investigator: | Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01624649 History of Changes |
| Other Study ID Numbers: | CR100744, CONCERTAATT4107, CON-KOR-5026 |
| Study First Received: | June 19, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Korea: Korea Food and Drug Administration (KFDA) Republic of Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Attention-deficit hyperactivity disorder Developmental disorder Atomoxetine Methylphenidate Psychiatric disorder |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate Atomoxetine Dopamine Uptake Inhibitors |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 23, 2013