Clinical trial NCT01624649: A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
Official title: Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-deficit Hyperactivity Disorder
Keywords: Attention-deficit hyperactivity disorder
Developmental disorder
Atomoxetine
Methylphenidate
Psychiatric disorder
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 289
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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 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.

Primary outcomes:
measure: Change from baseline in the ADHD Rating Scale (ARS)
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline to Week 52
measure: Adherence Rate
timeFrame: Week 4 to Week 52
measure: Comprehensive Attention Test (CAT)
timeFrame: Baseline, Week 24 and Week 52
measure: Academic Performance Rating Scale (APRS)
timeFrame: Baseline, Week 24 and Week 52
measure: Symptoms Checklist (SCL-90) for Parent Depression
timeFrame: Baseline, Week 24 and Week 52
measure: Clinical Global Impression- Improvement (CGI-I)
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
city: Bucheon-Si Gyeonggi-Do
country: Korea, Republic of
city: Dae-Gu
country: Korea, Republic of
city: Gyeongsangnam-Do
country: Korea, Republic of
city: Jeju Special Self-Governing Province
country: Korea, Republic of
city: Jeonju-Si
country: Korea, Republic of
city: Kyunggi-Do
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: PRINCIPAL_INVESTIGATOR
References: