Attention-deficit Hyperactivity DisorderNCT01624649
A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
An observational study of Attention-deficit Hyperactivity Disorder, run by Janssen Korea, Ltd., Korea at 9 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Attention-deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate hydrochloride and Atomoxetine
- Type of treatment
- Pill or oral medicine
- How many people
- 289 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Feb 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Study site
Bucheon-Si Gyeonggi-Do
Study site
Daegu
Study site
Gyeongsangnam-Do
Study site
Jeju Special Self-Governing Province
Study site
Jeonju
Study site
Kyunggi-Do
Study site
Seongnam
Study site
Seoul
Study site
Suwon
About this study
Official title: Prospective Follow-Up Observational Study to Examine the Progression of 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).
Read the 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.
- Conditions
- Attention-deficit Hyperactivity Disorder
- Being tested
- Methylphenidate hydrochloride, Atomoxetine
- Keywords
- Attention-deficit hyperactivity disorder, Developmental disorder, Atomoxetine, Methylphenidate, Psychiatric disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Developmental Disabilities, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate hydrochlorideDrug
Form = tablet, route = oral, administered as a flexible dosage
AtomoxetineDrug
Form = tablet, route = oral;
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Methylphenidate hydrochloride; Drug: Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the ADHD Rating Scale (ARS)
The ADHD Rating Scale (ARS) - Parent Version: ARS contains 18 items, in which parent version of the questionnaire is based on home behaviors.
Measured: Baseline and Week 52
Secondary outcomes (6)
Clinical Global Impression-Severity (CGI-S)
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.
Measured: Baseline to Week 52
Adherence Rate
Pill count at each visit; at least 50% adherence rate will be considered clinically relevant.
Measured: Week 4 to Week 52
Comprehensive Attention Test (CAT)
CAT is a computerized test which includes attention task, sustained attention to response, flanker task, divided attention task, and spatial working memory task.
Measured: Baseline, Week 24 and Week 52
Academic Performance Rating Scale (APRS)
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.
Measured: Baseline, Week 24 and Week 52
Symptoms Checklist (SCL-90) for Parent Depression
Measured: Baseline, Week 24 and Week 52
Clinical Global Impression- Improvement (CGI-I)
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.
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Principal investigator, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624649
- Sponsor's protocol ID
- CR100744
- Other IDs
- CONCERTAATT4107, CON-KOR-5026
- Status last verified
- Jun 2015
- First submitted
- 19 Jun 2012
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors
- ClinicalTrials.gov ID
- NCT01624649
- Acronym / sponsor ID
- CR100744
- Conditions
- Attention-deficit Hyperactivity Disorder
- Keywords
- Attention-deficit hyperactivity disorder, Developmental disorder, Atomoxetine, Methylphenidate, Psychiatric disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ADHD | – | Drug: Methylphenidate hydrochloride, Drug: AtomoxetinePatients 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 |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate hydrochlorideForm = tablet, route = oral, administered as a flexible dosage | Drug | Patients with ADHD |
| AtomoxetineForm = tablet, route = oral; | Drug | Patients with ADHD |
Primary outcome
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.
6 secondary outcomes
Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline to Week 52
Adherence Rate
Time frame: Week 4 to Week 52
Comprehensive Attention Test (CAT)
Time frame: Baseline, Week 24 and Week 52
Academic Performance Rating Scale (APRS)
Time frame: Baseline, Week 24 and Week 52
Symptoms Checklist (SCL-90) for Parent Depression
Time frame: Baseline, Week 24 and Week 52
Clinical Global Impression- Improvement (CGI-I)
Time frame: Baseline and Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial principal investigator
Janssen Korea, Ltd., Korea
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-deficit Hyperactivity Disorder, run by Janssen Korea, Ltd., Korea at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the ADHD Rating Scale (ARS) (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.