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

NCT01339286 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-04-20

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

atomoxetine

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01339286 on ClinicalTrials.gov