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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01339286
• Other study ID #: NSFC30800302
• Status: Recruiting
• Phase: Phase 4
• First received: April 14, 2011
• Last updated: April 19, 2011
• Start date: March 2011

Study information

• Verified date: April 2011
• Source: Peking University
• Contact: Li Yang, MD PHD
• Phone: 86-10-62350880
• Email: lyangli375[@]126.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Sixth Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Side effect	Number of Subjects with Side effects	An expected average of 8 weeks	Yes