Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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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.

Official Title
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Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: atomoxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atomoxetine<br> | Drug: atomoxetine<br>* Atomoxetine will be titrated to optimal dose, beginning with 0.5mg/kg.d, then increasing to 1.2mg/kg.d in two weeks and maintaining for 4 weeks. If the optimal dose does not achieved, the dose can be increased further to 1.4mg/kg.d and maintained for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated) | Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks | an expected average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated) | Change from baseline in ADHD Rating Scale: IV (Parent Rated) after optimal dose treated for 4 weeks | an expected average of 8 weeks | 
| Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated) | Change from baseline in ADHD Rating Scale: IV (Teacher Rated) after optimal dose treated for 4 weeks | An expected average of 8 weeks | 
| Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated) | Change from baseline in IOWA Conners Rating Scale (Parent Rated) after optimal dose treated for 4 weeks | An expected average of 8 weeks | 
| Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated) | Change from baseline in IOWA Conners Rating Scale (Teacher Rated) after optimal dose treated for 4 weeks | An expected average of 8 weeks | 
| Improvement in Clinical Global Impression: Severity | Change from baseline in Clinical Global Impression: Severity after optimal dose treated for 4 weeks | An expected average of 8 weeks | 
| Side effect | Number of Subjects with Side effects | An expected average of 8 weeks |