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

NCT01339286 | Unknown Phase 4 DMC

• 1 other identifier: NSFC30800302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)

  an expected average of 8 weeks

• Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)

  An expected average of 8 weeks

• Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)

  An expected average of 8 weeks

• Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)

  An expected average of 8 weeks

• Improvement in Clinical Global Impression: Severity

  An expected average of 8 weeks

Study Arms (1)

atomoxetine

EXPERIMENTAL

Drug: atomoxetine

Interventions

atomoxetine 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.

atomoxetine

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Central Study Contacts

Li Yang, MD PHD

CONTACT

86-10-62350880; lyangli375@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 20, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: April 20, 2011

Record last verified: 2011-04

Locations

CN (1)