Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
atomoxetine
Sponsored by
About this trial
This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder
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.
Sites / Locations
- Peking University Sixth HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
atomoxetine
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Improvement in Clinical Global Impression: Severity
Change from baseline in Clinical Global Impression: Severity after optimal dose treated for 4 weeks
Side effect
Number of Subjects with Side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01339286
Brief Title
Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
atomoxetine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)
Description
Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks
Time Frame
an expected average of 8 weeks
Secondary Outcome Measure Information:
Title
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)
Description
Change from baseline in ADHD Rating Scale: IV (Parent Rated) after optimal dose treated for 4 weeks
Time Frame
an expected average of 8 weeks
Title
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)
Description
Change from baseline in ADHD Rating Scale: IV (Teacher Rated) after optimal dose treated for 4 weeks
Time Frame
An expected average of 8 weeks
Title
Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)
Description
Change from baseline in IOWA Conners Rating Scale (Parent Rated) after optimal dose treated for 4 weeks
Time Frame
An expected average of 8 weeks
Title
Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)
Description
Change from baseline in IOWA Conners Rating Scale (Teacher Rated) after optimal dose treated for 4 weeks
Time Frame
An expected average of 8 weeks
Title
Improvement in Clinical Global Impression: Severity
Description
Change from baseline in Clinical Global Impression: Severity after optimal dose treated for 4 weeks
Time Frame
An expected average of 8 weeks
Title
Side effect
Description
Number of Subjects with Side effects
Time Frame
An expected average of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yang, MD PHD
Phone
86-10-62350880
Email
lyangli375@126.com
Facility Information:
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD PHD
Phone
86-10-62350880
Email
lyangli375@126.com
12. IPD Sharing Statement
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Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)
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