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

This study is currently recruiting participants.
Verified May 2013 by Janssen Korea, Ltd., Korea
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01624649
First received: June 19, 2012
Last updated: May 10, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624649

Contacts
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

Locations
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
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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 22, 2013