Attention Deficit Hyperactivity DisorderNCT01447004
a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea
An observational study of Attention Deficit Hyperactivity Disorder, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
Heavy metal has been reported that it can cause attention deficit and behavioral disturbance. The investigators hypothesis is that heavy metal is associated with children with attention deficit/hyperactivity disorder(ADHD). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to not given
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview
Who may be able to join
- Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview
- Subjects signed a written consent form voluntarily.
- Patient 's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates, or legal guardian.
- Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time
Who cannot join
- Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
- Subjects who have significant suicidal ideation or homicidal ideation
- Subjects with mental retardation
- Subjects with Tourette's syndrome requiring drug therapy.
- Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma).
- Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology.
- Subjects who have been administrated alpha-2 adrenergic receptor agonist,antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant within recent 2 months.
- Subjects who dyed their hair within 8 weeks
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym university sacred heart hospital
Anyang, Gyeonggi-do
Hyun Ju Hong, +82-31-380-3750
About this study
Heavy metal has been reported that it can cause attention deficit and behavioral disturbance. The investigators hypothesis is that heavy metal is associated with children with attention deficit/hyperactivity disorder(ADHD).
- 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 posted5 Oct 2011 (estimated)
- Study startMar 2010
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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447004
- Sponsor's protocol ID
- hushhirb
- Status last verified
- Feb 2010
- First submitted
- 4 Oct 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea
- ClinicalTrials.gov ID
- NCT01447004
- Acronym / sponsor ID
- hushhirb
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- First posted
- 5 Oct 2011 (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.
Heavy metal has been reported that it can cause attention deficit and behavioral disturbance. The investigators hypothesis is that heavy metal is associated with children with attention deficit/hyperactivity disorder(ADHD).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview
Key inclusion criteria (4 listed)
- Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview
Key exclusion criteria (8 listed)
- Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
- Subjects who have significant suicidal ideation or homicidal ideation
- Subjects with mental retardation
- Subjects with Tourette's syndrome requiring drug therapy.
- Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma).
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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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.
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 Hallym University Medical Center at 1 site 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Ju Hong (+82-31-380-3750, hongdr@chol.com, hjhong@hallym.or.kr), or a site near the patient. 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 5 Oct 2011.