Attention Deficit Disorder With HyperactivityNCT00598182
Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The objectives of this study are to investigate: 1. the evolution of ADHD symptoms, remission rate of ADHD, social and school function, and familial relationship; 2. the adherence to CONCERTA, treatment modality, and average treatment duration during the 3-year follow-up period; and 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who were diagnosed as DSM-IV ADHD and participated in the randomized clinical trial for CONCERTA at NTUH Taiwan will be enrolled into this study.
Who may be able to join
- Subjects who participated the randomized clinical trial for CONCERTA on NTUH.
- Subjects whose parents/caregivers can complete the questionnaires during the study and can assist to finish the assessment properly during the study;
- Subjects whose parent(s) or guardian(s) has signed and dated an informed consent for the subject to participate in the study.
Who cannot join
- No.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
The objectives of this study are to investigate:
- the evolution of ADHD symptoms, remission rate of ADHD, social and school function, and familial relationship;
- the adherence to CONCERTA, treatment modality, and average treatment duration during the 3-year follow-up period; and
- the effect of medication on the changes of neuropsychological functioning.
Read the detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a common impairing disease among children and adolescents. Methylphenidate, a stimulant, is effective in treating these patients. OROS methylphenidate (CONCERTA) provides ADHD patients a more convenient and safer treatment approach than immediate-release methylphenidate (IR-MPH). However, there is little information of long-term effect and adherence to CONCERTA. At the NTUH Taiwan, a randomized clinical trial of OROS MPH was performed 3 years ago and 64 subjects were included and treated with either IR MPH or OROS MPH followed by OROS MPH. Therefore, we purpose this study to follow up these patients, exploring the adherence rate to CONCERTA, symptoms evolution, and outcomes among these patients.
Overview of Study Design: There will be two stages of this study. All study procedures will be performed after obtaining informed consent.
Stage I: Medical charts of these subjects will be reviewed to obtain information about CONCERTA adherence (also including dosage, treatment duration, clinic visits, missing visits etc.), psychiatric co-morbidities, and other treatment approaches subjects received after the previous study. Subjects will be visited (Visit 1) and the information of baseline characteristics and reasons for discontinuing CONCERTA (if applicable) will be recorded. The assessments will included parent or teacher ratings on the Conner's Teacher and Parent Rating scales (CPRS-R:S, CTRS-R:S), the SNAP-IV rating scale, the SKAMP rating scale, investigator ratings on the Kiddie-SADS-E, Clinical Global Impression and the Social Adjustment Inventory for Children and Adolescents (SAICA); and neuropsychological assessments (Conner's Continuous Performance Test, CPT, and Cambridge Neuropsychological Test Automated Batteries, CANTA B) will be performed to these subjects.
Stage II: All subjects enrolled into stage one will be followed for the next 6 months. Medication for ADHD treatment may be used to these subjects based on investigators' clinical judgments. Subjects will visit clinics in week-24 (Visit 2). The same assessments at Visit 1 will be performed at Visit 2. In addition, the adherence to treatment, adverse events, overall satisfaction to treatment, and academic performances during these 6 months will be recorded.
- Keywords
- Attention Deficit Disorder with Hyperactivity, OROS methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startSep 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598182
- Sponsor's protocol ID
- 200709022R
- Status last verified
- Apr 2012
- First submitted
- 9 Jan 2008
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT00598182
- Acronym / sponsor ID
- 200709022R
- Keywords
- Attention Deficit Disorder with Hyperactivity, OROS methylphenidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Jan 2008 (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 objectives of this study are to investigate:
- the evolution of ADHD symptoms, remission rate of ADHD, social and school function, and familial relationship;
- the adherence to CONCERTA, treatment modality, and average treatment duration during the 3-year follow-up period; and
- the effect of medication on the changes of neuropsychological functioning.
Detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a common impairing disease among children and adolescents. Methylphenidate, a stimulant, is effective in treating these patients. OROS methylphenidate (CONCERTA) provides ADHD patients a more convenient and safer treatment approach than immediate-release methylphenidate (IR-MPH). However, there is little information of long-term effect and adherence to CONCERTA. At the NTUH Taiwan, a randomized clinical trial of OROS MPH was performed 3 years ago and 64 subjects were included and treated with either IR MPH or OROS MPH followed by OROS MPH. Therefore, we purpose this study to follow up these patients, exploring the adherence rate to CONCERTA, symptoms evolution, and outcomes among these patients.
Overview of Study Design: There will be two stages of this study. All study procedures will be performed after obtaining informed consent.
Stage I: Medical charts of these subjects will be reviewed to obtain information about CONCERTA adherence (also including dosage, treatment duration, clinic visits, missing visits etc.), psychiatric co-morbidities, and other treatment approaches subjects received after the previous study. Subjects will be visited (Visit 1) and the information of baseline characteristics and reasons for discontinuing CONCERTA (if applicable) will be recorded. The assessments will included parent or teacher ratings on the Conner's Teacher and Parent Rating scales (CPRS-R:S, CTRS-R:S), the SNAP-IV rating scale, the SKAMP rating scale, investigator ratings on the Kiddie-SADS-E, Clinical Global Impression and the Social Adjustment Inventory for Children and Adolescents (SAICA); and neuropsychological assessments (Conner's Continuous Performance Test, CPT, and Cambridge Neuropsychological Test Automated Batteries, CANTA B) will be performed to these subjects.
Stage II: All subjects enrolled into stage one will be followed for the next 6 months. Medication for ADHD treatment may be used to these subjects based on investigators' clinical judgments. Subjects will visit clinics in week-24 (Visit 2). The same assessments at Visit 1 will be performed at Visit 2. In addition, the adherence to treatment, adverse events, overall satisfaction to treatment, and academic performances during these 6 months will be recorded.
Study design
- Observational model
- Case only
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who were diagnosed as DSM-IV ADHD and participated in the randomized clinical trial for CONCERTA at NTUH Taiwan will be enrolled into this study.
Key inclusion criteria (3 listed)
- Subjects who participated the randomized clinical trial for CONCERTA on NTUH.
- Subjects whose parents/caregivers can complete the questionnaires during the study and can assist to finish the assessment properly during the study;
- Subjects whose parent(s) or guardian(s) has signed and dated an informed consent for the subject to participate in the study.
Key exclusion criteria (1 listed)
- No.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 17 May 2012.
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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.
Susan Shur-Fen Gau, MD, PhD principal investigator
National Taiwan University Hospital
1 site 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 Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 1 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 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
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 17 May 2012.