Clinical trial NCT01339286: Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements, professions and social livings are impaired. Comorbid antisocial behavior, substance abuse and delinquency burden family and society. Stimulants used to be the first line drug. But the medication compliance is poor because of strict drug administration. Atomoxetine is a new non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect slowly, the drug responses differ significantly, and side effects interfere compliance. Since genetic factors is the most important cause for different drug responses, this project studies candidate genes potentially associated with atomoxetine medication, with the aim to find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts cohort design. A sample of more than 100 ADHD cases with atomoxetine medication is to be collected. The rapid genotyping of large sample depends on high-through laboratory. New statistic method is to be used to improve the sensitivity of the target gene detection. There has been no such report in country and overseas. This project will provide basic information for forecasting drug response, improving clinical effects, tolerance and long-term compliance.


Eligibility criteria: Inclusion Criteria:

* The subject should meet with the DSM-IV ADHD criteria, confirmed by semi-structured interview.
* The subject has not accepted any treatment for ADHD before, or he/she received methylphenidate or atomoxetine treatment but has stopped for 1 or 4 weeks respectively.
* Han Chinese
* Parent sign the informed consent

Exclusion Criteria:

* Who are allergy to atomoxetine
* Who can not complete the titration procedure because of untolerable of the side effect
* Who combined other psychotropic drugs or non-drug intervention for ADHD.
* Children who can not be compliant with the blood withdraw.

Primary outcomes:
measure: Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)
timeFrame: an expected average of 8 weeks
Secondary outcomes:
measure: Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)
timeFrame: an expected average of 8 weeks
measure: Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)
timeFrame: An expected average of 8 weeks
measure: Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)
timeFrame: An expected average of 8 weeks
measure: Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)
timeFrame: An expected average of 8 weeks
measure: Improvement in Clinical Global Impression: Severity
timeFrame: An expected average of 8 weeks
measure: Side effect
timeFrame: An expected average of 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
Study officials:
References: