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

NCT ID: NCT01339286

Last Updated: 2011-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

atomoxetine

Group Type: EXPERIMENTAL

atomoxetine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Peking University the Sixth Hospital

Locations

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Yang, MD PHD

Role: CONTACT

lyangli375@126.com

86-10-62350880

Facility Contacts

Li Yang, MD PHD

Role: primary

lyangli375@126.com

86-10-62350880

Other Identifiers

NSFC30800302

Identifier Type: -

Identifier Source: org_study_id