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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01624649
First received: June 19, 2012
Last updated: June 30, 2014
Last verified: June 2014
  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: Observational
Study Design: 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

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.


Enrollment: 279
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Seognam-Si, Kyungki-Do, Korea, Republic of
Seoul, Korea, Republic of
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

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: June 30, 2014
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
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on August 20, 2014