Attention Deficit Hyperactivity DisorderNCT01677819
Inhibition Control of Children and Adolescents With ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The objectives of this study are to investigate: 1. the effect of methylphenidate on attention; 2. the relations between methylphenidate and inhibition control and working memory; 3. the relations between inhibition control and verbal attention and working memory; 4. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2011to Mar 2012
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We will recruit 60 children and adolescents, aged 10 to 18, who are diagnosed with ADHD at the Department of Psychiatry, National Taiwan University Hospital.
Who may be able to join
- The inclusion criteria for the subjects are (1)that subjects have a clinical diagnosis of ADHD defined by the DSM-IV which was made by a full-time board-certificated child psychiatrist; (2)their ages range from 10 to 18 when we conduct the study; (3)their IQ greater than 80; and (4)they are under treatment of methylphenidate.
Who cannot join
- The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhibition Control of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
The objectives of this study are to investigate:
- the effect of methylphenidate on attention;
- the relations between methylphenidate and inhibition control and working memory;
- the relations between inhibition control and verbal attention and working memory;
- the effect of methylphenidate on the changes of neuropsychological functioning and blood pressure.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 5-10% of school-aged children worldwide (7.5% in Taiwan). Methylphenidate, a stimulant, is effective in treating these patients. Studies in Taiwan show no effect of methylphenidate on blood pressure. There are evidences show that the change of blood pressure was associated with inhibition of impulsive behaviors. Stop Signal Task(SST) is used to assess the improve of inhibition control after methylphenidate response. By using repeated outcome measurements, we anticipate that this study will evaluate the improvement of neuropsychological performances after medication and determinie the association between medication response and neuropsychological functions and vital signs in a Taiwanese sample.
- Conditions
- Attention Deficit Hyperactivity Disorder
- 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 posted3 Sep 2012 (estimated)
- Study startNov 2011
- Study completionMar 2012
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.
- 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
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677819
- Sponsor's protocol ID
- 201109027RD
- Status last verified
- Aug 2012
- First submitted
- 30 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition Control of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01677819
- Acronym / sponsor ID
- 201109027RD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Sep 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 objectives of this study are to investigate:
- the effect of methylphenidate on attention;
- the relations between methylphenidate and inhibition control and working memory;
- the relations between inhibition control and verbal attention and working memory;
- the effect of methylphenidate on the changes of neuropsychological functioning and blood pressure.
Detailed description
Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 5-10% of school-aged children worldwide (7.5% in Taiwan). Methylphenidate, a stimulant, is effective in treating these patients. Studies in Taiwan show no effect of methylphenidate on blood pressure. There are evidences show that the change of blood pressure was associated with inhibition of impulsive behaviors. Stop Signal Task(SST) is used to assess the improve of inhibition control after methylphenidate response. By using repeated outcome measurements, we anticipate that this study will evaluate the improvement of neuropsychological performances after medication and determinie the association between medication response and neuropsychological functions and vital signs in a Taiwanese sample.
Study design
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We will recruit 60 children and adolescents, aged 10 to 18, who are diagnosed with ADHD at the Department of Psychiatry, National Taiwan University Hospital.
Key inclusion criteria (1 listed)
- The inclusion criteria for the subjects are (1)that subjects have a clinical diagnosis of ADHD defined by the DSM-IV which was made by a full-time board-certificated child psychiatrist; (2)their ages range from 10 to 18 when we conduct the study; (3)their IQ greater than 80; and (4)they are under treatment of methylphenidate.
Key exclusion criteria (1 listed)
- The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder.
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 3 Sep 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 & College of Medicine
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 Hyperactivity Disorder, 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 1 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 3 Sep 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 3 Sep 2012.