a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Hallym University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01447004
First received: October 4, 2011
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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).


Condition
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Estimated Enrollment: 100
Study Start Date: March 2010
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447004

Contacts
Contact: Hyun Ju Hong +82-31-380-3750 hongdr@chol.com, hjhong@hallym.or.kr

Locations
Korea, Republic of
Hallym university sacred heart hospital Recruiting
Anyang, Gyeonggi-do, Korea, Republic of
Contact: Hyun Ju Hong    +82-31-380-3750      
Sponsors and Collaborators
Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01447004     History of Changes
Other Study ID Numbers: hushhirb
Study First Received: October 4, 2011
Last Updated: October 4, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014