Status:
COMPLETED
Pharmacogenetic Studies on Attention Deficit Hyperactivity Disorder
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
7-18 years
Brief Summary
The ultimate goal of this study is to find the association between specific polymorphism of candidate genes and medication response in attention deficit hyperactivity disorder (ADHD) patients. These r...
Detailed Description
Background: The science of pharmacogenetics seeks to identify patterns of genetic variation that will direct individually tailored treatment regimens and enhance long-term adherence. Attention deficit...
Eligibility Criteria
Inclusion
- Patients are eligible to be included in this study only if they meet all of the following criteria:
- Patients will be outpatients who are between 7 and 18 years of age.
- Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental disorders, 4th edition (DSM-IV) disease diagnostic criteria assessed by the investigator's clinical evaluation, as well as confirmed by the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological Version (K-SADS-E).
- Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score \> 4 at Visit 1.
- Patients must be psychotropic medication-naïve. Patients will be considered to be medication-naïve if they have never received medications specifically to treat ADHD.
- Patients must have laboratory results, including serum chemistries, hematology, and urine analysis showing no significant abnormalities and no clinical information that should preclude a patient's participation at study entry. A patient with a significant abnormal laboratory result mat enter the study if, after appropriate medical evaluation, the result dose not indicate a serious medical condition that in the investigator's judgment would preclude participation.
- Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
- Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as achieving a score of 80 or more when IQ testing is administrated.
- Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including neuropsychological testing and venipunctures.
Exclusion
- Patients will be excluded from the study if they meet any of the following criteria:
- Patients with current or past history of schizophrenia, schizoaffective Disorder, organic psychosis, bipolar I or II disorder, autism, Asperger's disorder, or pervasive developmental disorder. Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the primary source of impairment for the patient.
- Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
- Patients have been at serious suicidal risk, determined by the investigator.
- Patients with a history of severe allergies to more than one class of medications or multiple adverse drug reactions.
- Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any described or over-the-counter medication in a manner that the investigator considers indicative of abuse.
- Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
- Patients who are likely to need psychotropic medications apart from methylphenidate or atomoxetine, including Chinese medicine or health-food supplements that have central nervous system activity.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00916786
Start Date
August 1 2009
End Date
July 31 2012
Last Update
September 2 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan