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Completed

NCT Number: NCT01624649

A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (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).

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Key information

Conditions

Attention-Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucheon-Si Gyeonggi-Do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylphenidate Hydrochloride

Drug

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

Atomoxetine

Drug

Form = tablet, route = oral;

Primary outcomes

  1. Change from baseline in the ADHD Rating Scale (ARS)

    Time frame: 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 outcomes

  1. Clinical Global Impression-Severity (CGI-S)

    Time frame: 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.

  2. Adherence Rate

    Time frame: Week 4 to Week 52

    Pill count at each visit; at least 50% adherence rate will be considered clinically relevant.

  3. Comprehensive Attention Test (CAT)

    Time frame: 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.

  4. Academic Performance Rating Scale (APRS)

    Time frame: 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.

  5. Symptoms Checklist (SCL-90) for Parent Depression

    Time frame: Baseline, Week 24 and Week 52

  6. Clinical Global Impression- Improvement (CGI-I)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2012
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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