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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01447004
• Other study ID #: hushhirb
• Status: Recruiting
• Phase: N/A
• First received: October 4, 2011
• Last updated: October 4, 2011
• Start date: March 2010

Study information

• Verified date: February 2010
• Source: Hallym University Medical Center
• Contact: Hyun Ju Hong
• Phone: +82-31-380-3750
• Email: hongdr[@]chol.com, hjhong[@]hallym.or.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Locations

Country	Name	City	State
Korea, Republic of	Hallym university sacred heart hospital	Anyang, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of,